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NCT00304031 · CITED IN SOURCE DOCUMENTS

Radiation Therapy (RT) and Temozolomide (TMZ) in Treating Patients With Newly Diagnosed Glioblastoma or Gliosarcoma

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2020-06-09

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known which schedule of temozolomide when given together with radiation therapy is more effective in treating glioblastoma or gliosarcoma. PURPOSE: This randomized phase III trial is studying two different schedules of temozolomide to compare how well they work when given together with radiation therapy in treating patients with newly diagnosed glioblastoma or gliosarcoma.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Median Overall Survival Time

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outcome · POSTED

Median Progression-free Survival (PFS) Time

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outcome · POSTED

Median Overall Survival Time by MGMT Status

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outcome · POSTED

Median Progression-free Survival Time by MGMT Status

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outcome · POSTED

Best Treatment Response by MGMT Status

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outcome · POSTED

Distribution of Highest Grade AE Reported as Possibly/Probably/Definitely Related to Protocol Treatment

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outcome · POSTED

Overall Survival Status by Progression Status at 6 Months

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outcome · POSTED

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

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outcome · POSTED

Mean Neurocognitive Function (NCF) Composite Score at Cycle 10 for Participants Without Progression After 6 Months of Adjuvant Therapy

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outcome · POSTED

Mean EORTC QLQ-C30 Global Health Status Score at Cycle 10 for Participants Without Progression After 6 Months of Adjuvant Therapy

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outcome · POSTED

Mean Change From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score at Mid-cyle for Cycle 1

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outcome · POSTED

Mean Change From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score at Mid-cyle for Cycle 4

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outcome · POSTED

Mean Change From Baseline in EORTC QLQ-C30 Global Health Status Score at Mid-cyle for Cycle 1

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outcome · POSTED

Mean Change From Baseline in EORTC QLQ-C30 Global Health Status Score at Mid-cyle for Cycle 4

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outcome · POSTED

Change From Baseline in Mean EORTC QLQ-C30 Global Health Status

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outcome · POSTED

Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score at Cycle 4

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outcome · POSTED

Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Interference Score at Cycle 4

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

Mean MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score Over Time

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outcome · POSTED

Determination of Impactful Baseline Instruments on Overall Survival

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outcome · POSTED

Mean Neurocognitive Function (NCF) Composite Score Over Time

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion criteria: 1. Histopathologically proven diagnosis of glioblastoma. Since gliosarcoma is a variant of glioblastoma, gliosarcoma is also an eligible diagnosis. 2. Patients must have at least 1 block of tissue available for analysis of MGMT status; fresh frozen tumor tissue acquisition is encouraged. 3. Diagnosis must be established by open biopsy or tumor resection. Patients who have only had a stereotactic biopsy are not eligible. 4. The tumor must have a supratentorial component. 5. Patients must have recovered from the effects of surgery, postoperative infection, and other complications before study registration. 6. A diagnostic contrast-enhanced magnetic resonance imaging (MRI) or computerized tomography (CT) scan (if MRI is not available) of the brain must be performed preoperatively and postoperatively. The postoperative scan must be done within 28 days of registration and prior to the initiation of radiotherapy. Preoperative and postoperative scans must be the same type. If CT scans were performed perioperatively, a CT and an MRI should be performed before randomization. 6.1. Patients unable to undergo MRI imaging because of non-compatible devices can be enrolled, provided pre- and post-operative contrast-enhanced CT scans are obtained and are of sufficient quality. 7. Therapy must begin ≤ 5 weeks after the most recent brain tumor surgery. 8. History/physical examination within 14 days prior to study registration. 9. Neurologic examination within 14 days prior to study registration. 10. Documentation of steroid doses within 14 days prior to study registration and stable or decreasing steroid dose within 5 days prior to registration. 11. Karnofsky performance status of ≥ 60. 12. Age ≥ 18 years. 13. Complete blood count (CBC)/differential obtained within 14 days prior to study registration, with adequate bone marrow function as defined below: 13.1 Absolute neutrophil count (ANC) ≥ 1500 cells/mm3. 13.2 Platelets ≥ 100,000 cells/mm3. 13.3 Hemoglobin ≥ 10 g/dl. (Note: The use of transfusion or other intervention to achieve Hgb ≥ 10 g/dl is acceptable.) 14. Adequate renal function, as defined below: 14.1 Blood urea nitrogen (BUN) ≤ 25 mg/dl within 14 days prior to study registration 14.2 Creatinine ≤ 1.7 mg/dl within 14 days prior to study registration 15. Adequate hepatic function, as defined below: 15.1 Bilirubin ≤ 2.0 mg/dl within 14 days prior to study registration 15.2 Alanine aminotransferase (ALT) ≤ 3 x normal range within 14 days prior to study registration 15.3 Aspartate aminotransferase (AST) ≤ 3 x normal range within 14 days prior to study registration 16. Patients must sign a study-specific informed consent prior to study registration. If the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the responsible family member. 17. For females of child-bearing potential, negative serum pregnancy test within 72 hours prior to starting temozolomide. 18. Women of childbearing potential and male participants must practice adequate Exclusion criteria: 1. Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 3 years. (For example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible). 2. Recurrent or multifocal malignant gliomas 3. Metastases detected below the tentorium or beyond the cranial vault. 4. Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable. Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted. See Section 1. 5. Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields. 6. Severe, active co-morbidity, defined as follows: * 6.1. Unstable angina and/or congestive heart failure requiring hospitalization. * 6.2. Transmural myocardial infarction within the last 6 months. * 6.3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration. * 6.4. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration. * 6.5. Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol. * 6.6. Acquired Immune Deficiency Syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. * 6.7. Major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy. * 6.8. Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity. 7. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic. 8. Pregnant or lactating women, due to possible adverse effects on the developing fetus or infant due to study drug; 9. Prior allergic reaction to temozolomide. 10. Patients treated on any other therapeutic clinical protocols within 30 days prior to study entry or during participation in the study. 11. No tissue provided for histopathologic central review and MGMT status. 12. Tissue provided by stereotactic biopsy method.
healthy Volunteers
false
maximum Age
120 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Drug: Concurrent temozolomide
    2. Radiation: Concurrent radiation therapy
    3. Drug: 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle
    label
    Conventional adjuvant TMZ
    type
    ACTIVE_COMPARATOR
  2. description
    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.
    intervention Names
    1. Drug: Concurrent temozolomide
    2. Radiation: Concurrent radiation therapy
    3. Drug: 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle
    label
    Dose-dense adjuvant TMZ
    type
    EXPERIMENTAL
  3. description
    Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Not randomized to either adjuvant TMZ arm.
    intervention Names
    1. Drug: Concurrent temozolomide
    2. Radiation: Concurrent radiation therapy
    label
    No adjuvant TMZ (not randomized )
    type
    OTHER
interventions
  1. arm Group Labels
    1. Conventional adjuvant TMZ
    2. Dose-dense adjuvant TMZ
    3. No adjuvant TMZ (not randomized )
    description
    Daily oral temozolomide (75 mg/m2) up to 49 doses.
    name
    Concurrent temozolomide
    type
    DRUG
  2. arm Group Labels
    1. Conventional adjuvant TMZ
    2. Dose-dense adjuvant TMZ
    3. No adjuvant TMZ (not randomized )
    description
    60 Gy in 2 Gy fractions
    name
    Concurrent radiation therapy
    type
    RADIATION
  3. arm Group Labels
    1. Conventional adjuvant TMZ
    description
    Oral temozolomide on days 1-5 of a 28-day cycle. Dose starts at 150mg/m2 for first cycle, increases to 200mg/m2 for subsequent cycles if no unacceptable toxicity. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease may receive up to 6 more courses of temozolomide.
    name
    100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle
    type
    DRUG
  4. arm Group Labels
    1. Dose-dense adjuvant TMZ
    description
    Oral temozolomide on days 1-21 of a 28-day cycle. Dose starts at 75mg/m2 for first cycle, increases to 100mg/m2 for subsequent cycles if no unacceptable toxicity. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease may receive up to 6 more courses of temozolomide.
    name
    75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
1173
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Median Overall Survival Time
    time Frame
    From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
secondary Outcomes
  1. description
    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.
    measure
    Median Progression-free Survival (PFS) Time
    time Frame
    From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
  2. description
    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.
    measure
    Median Overall Survival Time by MGMT Status
    time Frame
    From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
  3. description
    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.
    measure
    Median Progression-free Survival Time by MGMT Status
    time Frame
    From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
  4. description
    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.
    measure
    Best Treatment Response by MGMT Status
    time Frame
    From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
  5. description
    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.
    measure
    Distribution of Highest Grade AE Reported as Possibly/Probably/Definitely Related to Protocol Treatment
    time Frame
    From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
  6. description
    Overall survival time is defined as time from registration to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated by the Kaplan-Meier method. 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.
    measure
    Overall Survival Status by Progression Status at 6 Months
    time Frame
    From randomization to last follow-up. Maximum follow-up at time of analysis was 4.4 years.
  7. description
    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.
    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
    time Frame
    Baseline and cycle 10 (approximately 46 weeks)
  8. description
    The NCF Composite score is the arithmetic mean of the Hopkins Verbal Learning Test - Revised (HVLT-R) (Free Recall, Delayed Recall, Delayed Recognition), Trail Making Test Part A (TMTA), Trail Making Test Part B (TMTB), and Controlled Oral Word Association (COWA) test scores, all of which are standardized, adjusting for age, education, and gender as necessary, such that mean is 0 and standard deviation is 1. A participant must have at least 5 of the 6 scores. A higher composite score indicates better neurocognitive function.
    measure
    Mean Neurocognitive Function (NCF) Composite Score at Cycle 10 for Participants Without Progression After 6 Months of Adjuvant Therapy
    time Frame
    Baseline and cycle 10 (approximately 46 weeks)
  9. description
    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).
    measure
    Mean EORTC QLQ-C30 Global Health Status Score at Cycle 10 for Participants Without Progression After 6 Months of Adjuvant Therapy
    time Frame
    Baseline and cycle 10 (approximately 46 weeks)
  10. description
    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.
    measure
    Mean Change From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score at Mid-cyle for Cycle 1
    time Frame
    Baseline and mid-cycle 1 (approximately 12 weeks)
  11. description
    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.
    measure
    Mean Change From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score at Mid-cyle for Cycle 4
    time Frame
    Baseline and mid-cycle 4 (approximately 24 weeks)
  12. description
    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.
    measure
    Mean Change From Baseline in EORTC QLQ-C30 Global Health Status Score at Mid-cyle for Cycle 1
    time Frame
    Baseline and mid-cycle 1 (approximately 12 weeks)
Full study description
brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known which schedule of temozolomide when given together with radiation therapy is more effective in treating glioblastoma or gliosarcoma. PURPOSE: This randomized phase III trial is studying two different schedules of temozolomide to compare how well they work when given together with radiation therapy in treating patients with newly diagnosed glioblastoma or gliosarcoma.
detailed Description
OBJECTIVES: Primary * Determine if dose-intensifying (increasing the "dose-density") the adjuvant temozolomide component of the chemoradiation treatment enhances treatment efficacy as measured by overall survival of patients with newly diagnosed glioblastoma or gliosarcoma. Secondary * Determine if dose-intensifying the adjuvant temozolomide component of the chemoradiation treatment enhances treatment efficacy as measured by progression-free survival. * Determine in patients with unmethylated MGMT (O-6-methylguanine-DNA methyltransferase) if dose-intensifying the adjuvant temozolomide component of the chemoradiation treatment enhances treatment efficacy (overall and progression-free survival) compared with patients receiving conventional temozolomide dosing. * Determine in patients with methylated MGMT if dose-intensifying the adjuvant temozolomide component of the chemoradiation treatment enhances treatment efficacy (overall and progression-free survival) compared with patients receiving conventional temozolomide dosing. * Determine if there is an association between tumor MGMT gene methylation status and treatment response. * Compare and record the toxicities of the conventional and dose-intense chemotherapy regimens. * Evaluate whether 6-month progression-free survival is associated with overall survival. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to recursive partitioning analysis class (III vs IV vs V), MGMT gene methylation status (methylated vs nonmethylated vs indeterminate), and radiotherapy criteria used (standard vs revised European). After completion of study treatment, patients are followed every 3 months for 1 year, every 4 months for 2 years, and then every 6 months thereafter.
Source references
references
  1. citation
    Aldape KD, Wang M, Sulman EP, et al.: RTOG 0525: molecular correlates from a randomized phase III trial of newly diagnosed glioblastoma. [Abstract] J Clin Oncol 29 (Suppl 15): A-LBA2000, 2011.
    type
    RESULT
  2. citation
    Armstrong TS, Wefel JS, Wang M, et al.: Clinical utility of neurocognitive function (NCF), quality of life (QOL), and symptom assessment as prognostic factors for survival and measures of treatment effects on RTOG 0525. [Abstract] J Clin Oncol 29 (Suppl 15): A-2016, 2011.
    type
    RESULT
  3. citation
    Wang M, Dignam JJ, Won M, Curran W, Mehta M, Gilbert MR. Variation over time and interdependence between disease progression and death among patients with glioblastoma on RTOG 0525. Neuro Oncol. 2015 Jul;17(7):999-1006. doi: 10.1093/neuonc/nov009. Epub 2015 Feb 16.
    pmid
    25688120
    type
    RESULT
  4. citation
    Aldape KD, Jones G, Wang M, et al.: MGMT methylation testing in RTOG 0525: A phase III trial of newly diagnosed glioblastoma. [Abstract] J Clin Oncol 27 (Suppl 15): A-2051, 2009.
    type
    RESULT
  5. citation
    Gilbert MR, Wang M, Aldape KD, Stupp R, Hegi ME, Jaeckle KA, Armstrong TS, Wefel JS, Won M, Blumenthal DT, Mahajan A, Schultz CJ, Erridge S, Baumert B, Hopkins KI, Tzuk-Shina T, Brown PD, Chakravarti A, Curran WJ Jr, Mehta MP. Dose-dense temozolomide for newly diagnosed glioblastoma: a randomized phase III clinical trial. J Clin Oncol. 2013 Nov 10;31(32):4085-91. doi: 10.1200/JCO.2013.49.6968. Epub 2013 Oct 7.
    pmid
    24101040
    type
    RESULT
  6. citation
    Bell EH, Pugh SL, McElroy JP, Gilbert MR, Mehta M, Klimowicz AC, Magliocco A, Bredel M, Robe P, Grosu AL, Stupp R, Curran W Jr, Becker AP, Salavaggione AL, Barnholtz-Sloan JS, Aldape K, Blumenthal DT, Brown PD, Glass J, Souhami L, Lee RJ, Brachman D, Flickinger J, Won M, Chakravarti A. Molecular-Based Recursive Partitioning Analysis Model for Glioblastoma in the Temozolomide Era: A Correlative Analysis Based on NRG Oncology RTOG 0525. JAMA Oncol. 2017 Jun 1;3(6):784-792. doi: 10.1001/jamaoncol.2016.6020.
    pmid
    28097324
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        er, randomized, phase III trial conducted by the RTOG, EORTC, and the North Central Cancer Therapy Group, <a href="/clinicaltrials/NCT00304031">RTOG 0525</a> (NCT00304031), compared standard adjuvant temozolomide treatment (days 1&#8211;5 of a 28-day cycle) with a dose-dense schedule (days 1&#8211;21 of a 28-day cycle). All pati
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      1. context
        Updated: March 28, 2025
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        display
        March 28, 2025

    Preserved source evidence · Not medical advice