TriangleNCT00304031 · STUDY IN CONTEXT
Radiation Therapy (RT) and Temozolomide (TMZ) in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
Read the full study record and all posted results →
Linked outcomes
Overall survival time is defined as time from registration/randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Analysis occurred after 647 deaths were reported.
Progression is defined as greater than 25% increase in tumor area (two diameters) provided that the patient has not had his/her dose of steroids decreased since the last evaluation period. Progression-free survival time is defined as time from registration to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. A concomitant decrease in steroid dose will rule out a progression designation during the first 2 months after completion of radiation therapy. Analysis occurred after 647 deaths were reported.
Overall survival time is defined as time from randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Tumor tissue submitted at baseline was analyzed to determine MGMT (O\[6\]-methylguanine-DNA methyltransferase) promoter methylation status (methylated / unmethylated). Analysis occurred after 647 deaths were reported.
Progression is defined as greater than 25% increase in tumor area (two diameters) provided that the patient has not had his/her dose of steroids decreased since the last evaluation period. Progression-free survival time is defined as time from registration to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. A concomitant decrease in steroid dose will rule out a progression designation during the first 2 months after completion of radiation therapy. Tumor tissue submitted at baseline was analyzed to determine MGMT (O\[6\]-methylguanine-DNA methyltransferase) promoter methylation status (methylated / unmethylated). Analysis occurred after 647 deaths were reported.
Response assessed using Response Evaluation Criteria in Solid Tumors (RECIST v1.0): Complete Response (CR), imaging no longer shows enhancing tumor, confirmed by a second scan ≥ 4 weeks later; Partial Response (PR), \>=50% decrease in tumor area (two diameters) with patient off all steroids, or on adrenal maintenance only; Minor Response (MR), \< 50% decrease in tumor area with patient off all steroids, or on adrenal maintenance only; Stable Disease (SD): scan shows no change with patient receiving stable/decreasing doses of steroids; Progression (P): \> 25% increase in tumor area with no decrease in steroid dose since last evaluation. Tumor tissue submitted at baseline was analyzed to determine MGMT (O\[6\]-methylguanine-DNA methyltransferase) promoter methylation status (methylated / unmethylated). Analysis occurred after 647 deaths were reported.
Highest grade adverse event (AE) per subject was counted. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. Analysis occurred after 647 deaths were reported.
Reported safety
Quality of life and patient-reported measures
Patient-reported symptom or function measure · Mean MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score at Cycle 10 for Participants Without Progression After 6 Months of Adjuvant Therapy
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- qol key
- qol-0007
- source section id
- NCT00304031-om-0007
- source outcome index
- 7
- instrument
- Patient-reported symptom or function measure
- instrument basis
- matched 'patient-reported' in the study's own wording
- scale title
- Mean MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score at Cycle 10 for Participants Without Progression After 6 Months of Adjuvant Therapy
- measure definition
- The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). The symptom severity score is the average of the symptom severity items, given a specified minimum numbers were completed.
- time frame
- Baseline and cycle 10 (approximately 46 weeks)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Cycle 10 questionnaires were not completed by all quality of life (QOL) population participants progression-free at 6 months. Therefore, only 24/96 on the conventional arm and 20/95 on the dose-dense arm had data.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · Mean EORTC QLQ-C30 Global Health Status Score at Cycle 10 for Participants Without Progression After 6 Months of Adjuvant Therapy
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- qol key
- qol-0009
- source section id
- NCT00304031-om-0009
- source outcome index
- 9
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Mean EORTC QLQ-C30 Global Health Status Score at Cycle 10 for Participants Without Progression After 6 Months of Adjuvant Therapy
- measure definition
- Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ\]-C30. The question responses range from 1 "very poor" to 7 "excellent" such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best).
- time frame
- Baseline and cycle 10 (approximately 46 weeks)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher response indicates better
- population note
- Cycle 10 questionnaires were not completed by all QOL population participants progression-free at 6 months. Therefore, only 24/96 on the conventional arm and 22/95 on the dose-dense arm had data.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Patient-reported symptom or function measure · Mean Change From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score at Mid-cyle for Cycle 1
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- qol key
- qol-0010
- source section id
- NCT00304031-om-0010
- source outcome index
- 10
- instrument
- Patient-reported symptom or function measure
- instrument basis
- matched 'patient-reported' in the study's own wording
- scale title
- Mean Change From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score at Mid-cyle for Cycle 1
- measure definition
- The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). The symptom severity score is the average of the symptom severity items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration. Change is calculated as time point - baseline such that a positive change value indicates worse symptoms compared to baseline.
- time frame
- Baseline and mid-cycle 1 (approximately 12 weeks)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Questionnaires were not completed by all QOL population participants. Therefore, only 41/96 on the conventional arm and 35/95 on the dose-dense arm have both baseline and mid-cycle 1 data.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Patient-reported symptom or function measure · Mean Change From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score at Mid-cyle for Cycle 4
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- qol key
- qol-0011
- source section id
- NCT00304031-om-0011
- source outcome index
- 11
- instrument
- Patient-reported symptom or function measure
- instrument basis
- matched 'patient-reported' in the study's own wording
- scale title
- Mean Change From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score at Mid-cyle for Cycle 4
- measure definition
- The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). The symptom severity score is the average of the symptom severity items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration. Change is calculated as time point - baseline such that a positive change value indicates worse symptoms compared to baseline.
- time frame
- Baseline and mid-cycle 4 (approximately 24 weeks)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Questionnaires were not completed by all QOL population participants. Therefore, only 32/96 on the conventional arm and 24/95 on the dose-dense arm have both baseline and mid-cycle 4 data.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · Mean Change From Baseline in EORTC QLQ-C30 Global Health Status Score at Mid-cyle for Cycle 1
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- qol key
- qol-0012
- source section id
- NCT00304031-om-0012
- source outcome index
- 12
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Mean Change From Baseline in EORTC QLQ-C30 Global Health Status Score at Mid-cyle for Cycle 1
- measure definition
- Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ\]-C30. The question responses range from 1 "very poor" to 7 "excellent" such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Change is calculated as time point - baseline such that a positive change value indicates worse symptoms compared to baseline.
- time frame
- Baseline and mid-cycle 1 (approximately 12 weeks)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher response indicates better
- population note
- Questionnaires were not completed by all QOL population participants. Therefore, only 40/96 on the conventional arm and 38/95 on the dose-dense arm have both baseline and mid-cycle 1 data.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · Mean Change From Baseline in EORTC QLQ-C30 Global Health Status Score at Mid-cyle for Cycle 4
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- qol key
- qol-0013
- source section id
- NCT00304031-om-0013
- source outcome index
- 13
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Mean Change From Baseline in EORTC QLQ-C30 Global Health Status Score at Mid-cyle for Cycle 4
- measure definition
- Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ\]-C30. The question responses range from 1 "very poor" to 7 "excellent" such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Change is calculated as time point - baseline such that a positive change value indicates worse symptoms compared to baseline.
- time frame
- Baseline and mid-cycle 4 (approximately 24 weeks)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher response indicates better
- population note
- Questionnaires were not completed by all QOL population participants. Therefore, only 30/96 on the conventional arm and 23/95 on the dose-dense arm have both baseline and mid-cycle 4 data.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · Change From Baseline in Mean EORTC QLQ-C30 Global Health Status
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- qol key
- qol-0014
- source section id
- NCT00304031-om-0014
- source outcome index
- 14
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Change From Baseline in Mean EORTC QLQ-C30 Global Health Status
- measure definition
- Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ\]-C30. The question responses range from 1 "very poor" to 7 "excellent" such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Change from baseline was calculated as time point value - baseline value with a positive change value indicating improved QOL from baseline.
- time frame
- Baseline, 10,12, 22, 24, and 46 weeks
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher response indicates better
- population note
- Questionnaires were not completed by all QOL population participants. Therefore, the number of participants reported below are the number with the relevant questions answered at baseline and the given time point on each arm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Patient-reported symptom or function measure · Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score at Cycle 4
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- qol key
- qol-0015
- source section id
- NCT00304031-om-0015
- source outcome index
- 15
- instrument
- Patient-reported symptom or function measure
- instrument basis
- matched 'patient-reported' in the study's own wording
- scale title
- Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score at Cycle 4
- measure definition
- The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). The symptom severity score is the average of the symptom severity items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration.
- time frame
- baseline and cycle 4 (approximately 22 weeks)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Questionnaires were not completed by all QOL population participants. Therefore, only 51/96 on the conventional arm and 40/95 on the dose-dense arm have both baseline and cycle 4 data
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Patient-reported symptom or function measure · Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Interference Score at Cycle 4
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- qol key
- qol-0016
- source section id
- NCT00304031-om-0016
- source outcome index
- 16
- instrument
- Patient-reported symptom or function measure
- instrument basis
- matched 'patient-reported' in the study's own wording
- scale title
- Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Interference Score at Cycle 4
- measure definition
- The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity and resulting interference with daily living in brain cancer patients. All items range from 0 (did not interfere) to 10 (interfered completely). The symptom interference score is the average of the symptom interference items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration.
- time frame
- baseline and cycle 4 (approximately 22 weeks)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Questionnaires were not completed by all QOL population participants. Therefore, only 51/96 on the conventional arm and 40/95 on the dose-dense arm have both baseline and cycle 4 data
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score and EORTC QLQ-C30 Global Health Status Score (GHS) at Cycle 1
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- qol key
- qol-0017
- source section id
- NCT00304031-om-0017
- source outcome index
- 17
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score and EORTC QLQ-C30 Global Health Status Score (GHS) at Cycle 1
- measure definition
- * The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity (SS) and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). A SS score is the average of the SS items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration. * Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ\]-C30. The question responses range from 1 (very poor) to 7 (excellent) such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). A score worse than baseline by at least 10 is considered deterioration. * The 2x2 frequency table of SS deterioration vs. GHS deterioration is presented as four rows.
- time frame
- baseline and cycle 1 (approximately 10 weeks)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher response indicates better
- population note
- Per the protocol, both arms are combined. Questionnaires were not completed by all QOL population participants. Therefore, only 136/191 have both MDASI-BT and EORTC QLQ-C30 at baseline and cycle 1.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score and EORTC QLQ-C30 Global Health Status Score (GHS) at Cycle 4
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- qol key
- qol-0018
- source section id
- NCT00304031-om-0018
- source outcome index
- 18
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score and EORTC QLQ-C30 Global Health Status Score (GHS) at Cycle 4
- measure definition
- * The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity (SS) and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). A SS score is the average of the SS items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration. * Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ\]-C30. The question responses range from 1 (very poor) to 7 (excellent) such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). A score worse than baseline by at least 10 is considered deterioration. * The 2x2 frequency table of SS deterioration vs. GHS deterioration is presented as four rows.
- time frame
- baseline and cycle 4 (approximately 22 weeks)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher response indicates better
- population note
- Both arms are combined per the protocol. Questionnaires were not completed by all QOL population participants. Therefore, only 86/191 have both MDASI-BT and EORTC QLQ-C30 at baseline and cycle 4.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score and EORTC QLQ-C30 Global Health Status Score (GHS) at Cycle 10
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- qol key
- qol-0019
- source section id
- NCT00304031-om-0019
- source outcome index
- 19
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score and EORTC QLQ-C30 Global Health Status Score (GHS) at Cycle 10
- measure definition
- * The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity (SS) and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). A SS score is the average of the SS items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration. * Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ\]-C30. The question responses range from 1 (very poor) to 7 (excellent) such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). A score worse than baseline by at least 10 is considered deterioration. * The 2x2 frequency table of SS deterioration vs. GHS deterioration is presented as four rows.
- time frame
- baseline and cycle 10 (approximately 46 weeks)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher response indicates better
- population note
- Both arms are combined per the protocol. Questionnaires were not completed by all QOL population participants. Therefore, only 44/191 have both MDASI-BT and EORTC QLQ-C30 at baseline and cycle 10.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Patient-reported symptom or function measure · Mean MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score Over Time
Score direction: Not stated by the study. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- qol key
- qol-0020
- source section id
- NCT00304031-om-0020
- source outcome index
- 20
- instrument
- Patient-reported symptom or function measure
- instrument basis
- matched 'patient-reported' in the study's own wording
- scale title
- Mean MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score Over Time
- measure definition
- The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). The symptom severity score is the average of the symptom severity items, given a specified minimum numbers were completed.
- time frame
- Baseline, 10, 12, 22, 24, and 46 weeks
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Questionnaires were not completed by all QOL population participants. Therefore, the number of participants reported below are the number with the relevant questions answered at baseline and the given time point on each arm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
EORTC QLQ · Determination of Impactful Baseline Instruments on Overall Survival
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- qol key
- qol-0021
- source section id
- NCT00304031-om-0021
- source outcome index
- 21
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Determination of Impactful Baseline Instruments on Overall Survival
- measure definition
- Overall survival time is defined as time from registration/randomization to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ\]-C30 subscales are calculated as the mean of component items, then standardized such that subscale scores range from 0 to 100. A high score for a functional scale represents a healthy level of functioning. Controlled Oral Word Association (COWA) score is the sum of correct responses with a range of 0 to infinity. A higher score indicates better functioning. Hopkins Verbal Learning Test - Revised (HVLT-R) score ranges from 0 to 36 for total recall is 0 to 36, 0 to 12 for delayed recall, and -12 to 12 for recognition. A higher score indicates better functioning.
- time frame
- From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher score indicates better
- population note
- Both arms are combined per the protocol. Questionnaires/assessments were not completed by all QOL population participants. Therefore, only 154/191 have COWA, EORTC QLQ-C30, and HVLT-R baseline assessments (final model covariates)
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Patient-reported symptom or function measure · Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Cognitive Score and Hopkins Verbal Learning Test - Revised (HVLT-R) Delayed Recognition Score at Cycle 1
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- qol key
- qol-0023
- source section id
- NCT00304031-om-0023
- source outcome index
- 23
- instrument
- Patient-reported symptom or function measure
- instrument basis
- matched 'patient-reported' in the study's own wording
- scale title
- Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Cognitive Score and Hopkins Verbal Learning Test - Revised (HVLT-R) Delayed Recognition Score at Cycle 1
- measure definition
- * The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity (SS) and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). A SS score is the average of the SS items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration. * The HVLT-R Delayed Recognition raw score is the number of of correctly identified words minus the number of incorrectly identified words from a list of words including 12 nouns memorized 20 minutes prior. The raw score ranges from -12 to 12. with a higher score indicates better functioning. Scores are standardized (mean 0, standard deviation 1), adjusting for age,education, and gender as necessary. A score worse than baseline by at least two is considered deterioration. * The 2x2 frequency table of SS deterioration vs. HVLT-R deterioration is presented as four rows.
- time frame
- baseline and cycle 1 (approximately 10 weeks)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher score indicates better
- population note
- Both arms are combined per the protocol. Questionnaires/assessments were not completed by all QOL population participants. Therefore, only 116/191 have both MDASI-BT and HVLT-R at baseline and cycle 1.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Patient-reported symptom or function measure · Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Cognitive Score and Hopkins Verbal Learning Test - Revised (HVLT-R) Delayed Recognition (DR) Score at Cycle 4
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- qol key
- qol-0024
- source section id
- NCT00304031-om-0024
- source outcome index
- 24
- instrument
- Patient-reported symptom or function measure
- instrument basis
- matched 'patient-reported' in the study's own wording
- scale title
- Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Cognitive Score and Hopkins Verbal Learning Test - Revised (HVLT-R) Delayed Recognition (DR) Score at Cycle 4
- measure definition
- * The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity (SS) and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). A SS score is the average of the SS items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration. * The HVLT-R Delayed Recognition raw score is the number of of correctly identified words minus the number of incorrectly identified words from a list of words including 12 nouns memorized 20 minutes prior. The raw score ranges from -12 to 12. with a higher score indicates better functioning. Scores are standardized (mean 0, standard deviation 1), adjusting for age,education, and gender as necessary. A score worse than baseline by at least two is considered deterioration. * The 2x2 frequency table of SS deterioration vs. HVLT-R deterioration is presented as four rows.
- time frame
- baseline and cycle 4 (approximately 22 weeks)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher score indicates better
- population note
- Both arms are combined per the protocol. Questionnaires/assessments were not completed by all QOL population participants. Therefore, only 71/191 have both MDASI-BT and HVLT-R at baseline and cycle 4.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Patient-reported symptom or function measure · Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Cognitive Score and Hopkins Verbal Learning Test - Revised (HVLT-R) Delayed Recognition (DR) Score at Cycle 10
Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- qol key
- qol-0025
- source section id
- NCT00304031-om-0025
- source outcome index
- 25
- instrument
- Patient-reported symptom or function measure
- instrument basis
- matched 'patient-reported' in the study's own wording
- scale title
- Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Cognitive Score and Hopkins Verbal Learning Test - Revised (HVLT-R) Delayed Recognition (DR) Score at Cycle 10
- measure definition
- * The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity (SS) and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). A SS score is the average of the SS items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration. * The HVLT-R Delayed Recognition raw score is the number of of correctly identified words minus the number of incorrectly identified words from a list of words including 12 nouns memorized 20 minutes prior. The raw score ranges from -12 to 12. with a higher score indicates better functioning. Scores are standardized (mean 0, standard deviation 1), adjusting for age,education, and gender as necessary. A score worse than baseline by at least two is considered deterioration. * The 2x2 frequency table of SS deterioration vs. HVLT-R deterioration is presented as four rows.
- time frame
- baseline and cycle 10 (approximately 46 weeks)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher score indicates better
- population note
- Both arms are combined per the protocol. Questionnaires/assessments were not completed by all QOL population participants. Therefore, only 36/191 have both MDASI-BT and HVLT-R at baseline and cycle 10.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- trial label
- Radiation Therapy (RT) and Temozolomide (TMZ) in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- regulator-cited
- discovery note
- Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
- outcome Count
- 6
- harms Count
- 3
- qol Count
- 17
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- outcome key
- om-0000
- source section id
- NCT00304031-om-0000
- source outcome index
- 0
- endpoint
- Median Overall Survival Time
- endpoint definition
- Overall survival time is defined as time from registration/randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Analysis occurred after 647 deaths were reported.
- time origin
- From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Randomized eligible patients.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- outcome key
- om-0001
- source section id
- NCT00304031-om-0001
- source outcome index
- 1
- endpoint
- Median Progression-free Survival (PFS) Time
- endpoint definition
- Progression is defined as greater than 25% increase in tumor area (two diameters) provided that the patient has not had his/her dose of steroids decreased since the last evaluation period. Progression-free survival time is defined as time from registration to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. A concomitant decrease in steroid dose will rule out a progression designation during the first 2 months after completion of radiation therapy. Analysis occurred after 647 deaths were reported.
- time origin
- From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Randomized eligible patients
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- outcome key
- om-0002
- source section id
- NCT00304031-om-0002
- source outcome index
- 2
- endpoint
- Median Overall Survival Time by MGMT Status
- endpoint definition
- Overall survival time is defined as time from randomization to the date of death from any cause. Overall survival rates are estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. Tumor tissue submitted at baseline was analyzed to determine MGMT (O\[6\]-methylguanine-DNA methyltransferase) promoter methylation status (methylated / unmethylated). Analysis occurred after 647 deaths were reported.
- time origin
- From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- MGMT status was not available for all randomized eligible participants. Therefore, data was only available from 376/411 on the conventional arm and 384/420 on the dose-dense arm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- outcome key
- om-0003
- source section id
- NCT00304031-om-0003
- source outcome index
- 3
- endpoint
- Median Progression-free Survival Time by MGMT Status
- endpoint definition
- Progression is defined as greater than 25% increase in tumor area (two diameters) provided that the patient has not had his/her dose of steroids decreased since the last evaluation period. Progression-free survival time is defined as time from registration to the date of first progression, death, or last known follow-up (censored). Progression-free survival rates are estimated using the Kaplan-Meier method. A concomitant decrease in steroid dose will rule out a progression designation during the first 2 months after completion of radiation therapy. Tumor tissue submitted at baseline was analyzed to determine MGMT (O\[6\]-methylguanine-DNA methyltransferase) promoter methylation status (methylated / unmethylated). Analysis occurred after 647 deaths were reported.
- time origin
- From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- MGMT status was not available for all randomized eligible participants. Therefore, data was only available from 376/411 on the conventional arm and 384/420 on the dose-dense arm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- outcome key
- om-0004
- source section id
- NCT00304031-om-0004
- source outcome index
- 4
- endpoint
- Best Treatment Response by MGMT Status
- endpoint definition
- Response assessed using Response Evaluation Criteria in Solid Tumors (RECIST v1.0): Complete Response (CR), imaging no longer shows enhancing tumor, confirmed by a second scan ≥ 4 weeks later; Partial Response (PR), \>=50% decrease in tumor area (two diameters) with patient off all steroids, or on adrenal maintenance only; Minor Response (MR), \< 50% decrease in tumor area with patient off all steroids, or on adrenal maintenance only; Stable Disease (SD): scan shows no change with patient receiving stable/decreasing doses of steroids; Progression (P): \> 25% increase in tumor area with no decrease in steroid dose since last evaluation. Tumor tissue submitted at baseline was analyzed to determine MGMT (O\[6\]-methylguanine-DNA methyltransferase) promoter methylation status (methylated / unmethylated). Analysis occurred after 647 deaths were reported.
- time origin
- From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Per the protocol, both arms are combined to compare between MGMT status. MGMT status and treatment response was not available for all randomized eligible participants. Therefore, data was only available for 748/831 randomized eligible patients (arms combined).
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- outcome key
- om-0005
- source section id
- NCT00304031-om-0005
- source outcome index
- 5
- endpoint
- Distribution of Highest Grade AE Reported as Possibly/Probably/Definitely Related to Protocol Treatment
- endpoint definition
- Highest grade adverse event (AE) per subject was counted. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. Analysis occurred after 647 deaths were reported.
- time origin
- From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Randomized eligible patients with any adverse events reported as possibly/probably/definitely related to protocol treatment
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Conventional Adjuvant TMZ
- regimen
- Concurrent radiation therapy with concurrent temozolomide (TMZ) (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.
- analyzed count
- 411
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00304031-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Dose-dense Adjuvant TMZ
- regimen
- Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
- analyzed count
- 420
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00304031-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Conventional Adjuvant TMZ
- regimen
- Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.
- analyzed count
- 411
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00304031-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Dose-dense Adjuvant TMZ
- regimen
- Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
- analyzed count
- 420
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00304031-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Conventional Adjuvant TMZ
- regimen
- Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.
- analyzed count
- 376
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00304031-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Dose-dense Adjuvant TMZ
- regimen
- Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
- analyzed count
- 384
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00304031-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Conventional Adjuvant TMZ
- regimen
- Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.
- analyzed count
- 376
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00304031-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Dose-dense Adjuvant TMZ
- regimen
- Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
- analyzed count
- 384
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00304031-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Methylated
- regimen
- Methylated MGMT (O\[6\]-methylguanine-DNA methyltransferase)
- analyzed count
- 240
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00304031-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Unmethylated
- regimen
- Unmethylated MGMT (O\[6\]-methylguanine-DNA methyltransferase)
- analyzed count
- 508
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00304031-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Conventional Adjuvant TMZ
- regimen
- Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.
- analyzed count
- 351
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00304031-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Dose-dense Adjuvant TMZ
- regimen
- Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
- analyzed count
- 369
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00304031-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- harm key
- EG000
- source section id
- NCT00304031-ae
- event group key
- EG000
- event group label
- No Adjuvant TMZ (Not Randomized)
- serious affected
- 105
- serious at risk
- 285
- other affected
- 216
- other at risk
- 285
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Eligible participants with adverse event data: concurrent RT and TMZ only arm (not randomized): 285/292; conventional adjuvant TMZ arm: 409/411; dose-dense adjuvant TMZ arm: 420/422.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- harm key
- EG001
- source section id
- NCT00304031-ae
- event group key
- EG001
- event group label
- Conventional Adjuvant TMZ
- serious affected
- 131
- serious at risk
- 409
- other affected
- 376
- other at risk
- 409
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Eligible participants with adverse event data: concurrent RT and TMZ only arm (not randomized): 285/292; conventional adjuvant TMZ arm: 409/411; dose-dense adjuvant TMZ arm: 420/422.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- harm key
- EG002
- source section id
- NCT00304031-ae
- event group key
- EG002
- event group label
- Dose-dense Adjuvant TMZ
- serious affected
- 142
- serious at risk
- 420
- other affected
- 392
- other at risk
- 420
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Eligible participants with adverse event data: concurrent RT and TMZ only arm (not randomized): 285/292; conventional adjuvant TMZ arm: 409/411; dose-dense adjuvant TMZ arm: 420/422.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- qol key
- qol-0007
- source section id
- NCT00304031-om-0007
- source outcome index
- 7
- instrument
- Patient-reported symptom or function measure
- instrument basis
- matched 'patient-reported' in the study's own wording
- scale title
- Mean MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score at Cycle 10 for Participants Without Progression After 6 Months of Adjuvant Therapy
- measure definition
- The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). The symptom severity score is the average of the symptom severity items, given a specified minimum numbers were completed.
- time frame
- Baseline and cycle 10 (approximately 46 weeks)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Cycle 10 questionnaires were not completed by all quality of life (QOL) population participants progression-free at 6 months. Therefore, only 24/96 on the conventional arm and 20/95 on the dose-dense arm had data.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- qol key
- qol-0009
- source section id
- NCT00304031-om-0009
- source outcome index
- 9
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Mean EORTC QLQ-C30 Global Health Status Score at Cycle 10 for Participants Without Progression After 6 Months of Adjuvant Therapy
- measure definition
- Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ\]-C30. The question responses range from 1 "very poor" to 7 "excellent" such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best).
- time frame
- Baseline and cycle 10 (approximately 46 weeks)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher response indicates better
- population note
- Cycle 10 questionnaires were not completed by all QOL population participants progression-free at 6 months. Therefore, only 24/96 on the conventional arm and 22/95 on the dose-dense arm had data.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- qol key
- qol-0010
- source section id
- NCT00304031-om-0010
- source outcome index
- 10
- instrument
- Patient-reported symptom or function measure
- instrument basis
- matched 'patient-reported' in the study's own wording
- scale title
- Mean Change From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score at Mid-cyle for Cycle 1
- measure definition
- The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). The symptom severity score is the average of the symptom severity items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration. Change is calculated as time point - baseline such that a positive change value indicates worse symptoms compared to baseline.
- time frame
- Baseline and mid-cycle 1 (approximately 12 weeks)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Questionnaires were not completed by all QOL population participants. Therefore, only 41/96 on the conventional arm and 35/95 on the dose-dense arm have both baseline and mid-cycle 1 data.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- qol key
- qol-0011
- source section id
- NCT00304031-om-0011
- source outcome index
- 11
- instrument
- Patient-reported symptom or function measure
- instrument basis
- matched 'patient-reported' in the study's own wording
- scale title
- Mean Change From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score at Mid-cyle for Cycle 4
- measure definition
- The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). The symptom severity score is the average of the symptom severity items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration. Change is calculated as time point - baseline such that a positive change value indicates worse symptoms compared to baseline.
- time frame
- Baseline and mid-cycle 4 (approximately 24 weeks)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Questionnaires were not completed by all QOL population participants. Therefore, only 32/96 on the conventional arm and 24/95 on the dose-dense arm have both baseline and mid-cycle 4 data.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- qol key
- qol-0012
- source section id
- NCT00304031-om-0012
- source outcome index
- 12
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Mean Change From Baseline in EORTC QLQ-C30 Global Health Status Score at Mid-cyle for Cycle 1
- measure definition
- Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ\]-C30. The question responses range from 1 "very poor" to 7 "excellent" such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Change is calculated as time point - baseline such that a positive change value indicates worse symptoms compared to baseline.
- time frame
- Baseline and mid-cycle 1 (approximately 12 weeks)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher response indicates better
- population note
- Questionnaires were not completed by all QOL population participants. Therefore, only 40/96 on the conventional arm and 38/95 on the dose-dense arm have both baseline and mid-cycle 1 data.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- qol key
- qol-0013
- source section id
- NCT00304031-om-0013
- source outcome index
- 13
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Mean Change From Baseline in EORTC QLQ-C30 Global Health Status Score at Mid-cyle for Cycle 4
- measure definition
- Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ\]-C30. The question responses range from 1 "very poor" to 7 "excellent" such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Change is calculated as time point - baseline such that a positive change value indicates worse symptoms compared to baseline.
- time frame
- Baseline and mid-cycle 4 (approximately 24 weeks)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher response indicates better
- population note
- Questionnaires were not completed by all QOL population participants. Therefore, only 30/96 on the conventional arm and 23/95 on the dose-dense arm have both baseline and mid-cycle 4 data.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- qol key
- qol-0014
- source section id
- NCT00304031-om-0014
- source outcome index
- 14
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Change From Baseline in Mean EORTC QLQ-C30 Global Health Status
- measure definition
- Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ\]-C30. The question responses range from 1 "very poor" to 7 "excellent" such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). Change from baseline was calculated as time point value - baseline value with a positive change value indicating improved QOL from baseline.
- time frame
- Baseline, 10,12, 22, 24, and 46 weeks
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher response indicates better
- population note
- Questionnaires were not completed by all QOL population participants. Therefore, the number of participants reported below are the number with the relevant questions answered at baseline and the given time point on each arm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- qol key
- qol-0015
- source section id
- NCT00304031-om-0015
- source outcome index
- 15
- instrument
- Patient-reported symptom or function measure
- instrument basis
- matched 'patient-reported' in the study's own wording
- scale title
- Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score at Cycle 4
- measure definition
- The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). The symptom severity score is the average of the symptom severity items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration.
- time frame
- baseline and cycle 4 (approximately 22 weeks)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Questionnaires were not completed by all QOL population participants. Therefore, only 51/96 on the conventional arm and 40/95 on the dose-dense arm have both baseline and cycle 4 data
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- qol key
- qol-0016
- source section id
- NCT00304031-om-0016
- source outcome index
- 16
- instrument
- Patient-reported symptom or function measure
- instrument basis
- matched 'patient-reported' in the study's own wording
- scale title
- Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Interference Score at Cycle 4
- measure definition
- The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity and resulting interference with daily living in brain cancer patients. All items range from 0 (did not interfere) to 10 (interfered completely). The symptom interference score is the average of the symptom interference items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration.
- time frame
- baseline and cycle 4 (approximately 22 weeks)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- Source null
- direction quote
- Source null
- population note
- Questionnaires were not completed by all QOL population participants. Therefore, only 51/96 on the conventional arm and 40/95 on the dose-dense arm have both baseline and cycle 4 data
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- qol key
- qol-0017
- source section id
- NCT00304031-om-0017
- source outcome index
- 17
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score and EORTC QLQ-C30 Global Health Status Score (GHS) at Cycle 1
- measure definition
- * The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity (SS) and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). A SS score is the average of the SS items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration. * Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ\]-C30. The question responses range from 1 (very poor) to 7 (excellent) such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). A score worse than baseline by at least 10 is considered deterioration. * The 2x2 frequency table of SS deterioration vs. GHS deterioration is presented as four rows.
- time frame
- baseline and cycle 1 (approximately 10 weeks)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher response indicates better
- population note
- Per the protocol, both arms are combined. Questionnaires were not completed by all QOL population participants. Therefore, only 136/191 have both MDASI-BT and EORTC QLQ-C30 at baseline and cycle 1.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- qol key
- qol-0018
- source section id
- NCT00304031-om-0018
- source outcome index
- 18
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score and EORTC QLQ-C30 Global Health Status Score (GHS) at Cycle 4
- measure definition
- * The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity (SS) and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). A SS score is the average of the SS items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration. * Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ\]-C30. The question responses range from 1 (very poor) to 7 (excellent) such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). A score worse than baseline by at least 10 is considered deterioration. * The 2x2 frequency table of SS deterioration vs. GHS deterioration is presented as four rows.
- time frame
- baseline and cycle 4 (approximately 22 weeks)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher response indicates better
- population note
- Both arms are combined per the protocol. Questionnaires were not completed by all QOL population participants. Therefore, only 86/191 have both MDASI-BT and EORTC QLQ-C30 at baseline and cycle 4.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-central-nervous-system-tumors
- nct id
- NCT00304031
- qol key
- qol-0019
- source section id
- NCT00304031-om-0019
- source outcome index
- 19
- instrument
- EORTC QLQ
- instrument basis
- matched 'eortc' in the study's own wording
- scale title
- Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score and EORTC QLQ-C30 Global Health Status Score (GHS) at Cycle 10
- measure definition
- * The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity (SS) and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). A SS score is the average of the SS items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration. * Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ\]-C30. The question responses range from 1 (very poor) to 7 (excellent) such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). A score worse than baseline by at least 10 is considered deterioration. * The 2x2 frequency table of SS deterioration vs. GHS deterioration is presented as four rows.
- time frame
- baseline and cycle 10 (approximately 46 weeks)
- analysis role
- secondary
- reporting status
- POSTED
- higher is better
- 1
- direction quote
- higher response indicates better
- population note
- Both arms are combined per the protocol. Questionnaires were not completed by all QOL population participants. Therefore, only 44/191 have both MDASI-BT and EORTC QLQ-C30 at baseline and cycle 10.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- setting source links
Preserved source evidence · Not medical advice