TriangleNCT03930771 · STUDY IN CONTEXT
Capecitabine and Temozolomide for Treatment of Recurrent Pituitary Adenomas
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 by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Evaluation of Target lesions: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum onstudy (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Serum prolactin, IGF-1, ACTH, FSH, LH and TSH levels are used to assess changes in pituitary hormone function. These tests will only be repeated if found to be abnormal at baseline.
Safety, as Measured by the Number of Subjects With at Least One AE
Tolerability of the TMZ and Capecitabine Combination, as Measured by Number of Participants With a Dose-limiting Toxicity
Tumor invasiveness and aggressiveness, determined by assessing the relationship between select indicators (including Ki67 nuclear labelling index, p53 expression, MGMT expression/methylation status, and additional tumor genetic profiling) with response to chemotherapy, time to progression, and tumor invasiveness (based on the Knosp criteria).
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-adenoma
- nct id
- NCT03930771
- trial label
- Capecitabine and Temozolomide for Treatment of Recurrent Pituitary Adenomas
- 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
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 5
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-adenoma
- nct id
- NCT03930771
- outcome key
- om-0000
- source section id
- NCT03930771-om-0000
- source outcome index
- 0
- endpoint
- Number of Subjects With Radiographic Response, as Defined by the RECIST Criteria.
- endpoint definition
- Evaluation of Target lesions: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum onstudy (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
- time origin
- 6 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population 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-adenoma
- nct id
- NCT03930771
- outcome key
- om-0001
- source section id
- NCT03930771-om-0001
- source outcome index
- 1
- endpoint
- Effect of the CAP and TMZ Combination on Pituitary Function, Measured by Changes in Pituitary Hormone Secretion in Patients
- endpoint definition
- Serum prolactin, IGF-1, ACTH, FSH, LH and TSH levels are used to assess changes in pituitary hormone function. These tests will only be repeated if found to be abnormal at baseline.
- time origin
- At baseline and every 8 weeks, up to 6 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population 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-adenoma
- nct id
- NCT03930771
- outcome key
- om-0002
- source section id
- NCT03930771-om-0002
- source outcome index
- 2
- endpoint
- Safety, as Measured by the Number of Subjects With at Least One AE
- endpoint definition
- Safety, as Measured by the Number of Subjects With at Least One AE
- time origin
- 6 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population 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-adenoma
- nct id
- NCT03930771
- outcome key
- om-0003
- source section id
- NCT03930771-om-0003
- source outcome index
- 3
- endpoint
- Tolerability of the TMZ and Capecitabine Combination, as Measured by Number of Participants With a Dose-limiting Toxicity
- endpoint definition
- Tolerability of the TMZ and Capecitabine Combination, as Measured by Number of Participants With a Dose-limiting Toxicity
- time origin
- 6 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population 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-adenoma
- nct id
- NCT03930771
- outcome key
- om-0004
- source section id
- NCT03930771-om-0004
- source outcome index
- 4
- endpoint
- Tumor Invasiveness and Aggressiveness, Determined by Assessing the Relationship Between Select Indicators With Response to Chemotherapy, Time to Progression, and Tumor Invasiveness.
- endpoint definition
- Tumor invasiveness and aggressiveness, determined by assessing the relationship between select indicators (including Ki67 nuclear labelling index, p53 expression, MGMT expression/methylation status, and additional tumor genetic profiling) with response to chemotherapy, time to progression, and tumor invasiveness (based on the Knosp criteria).
- time origin
- 6 months
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Data was not collected in the specified time frame for this outcome measure.
- 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-adenoma
- nct id
- NCT03930771
- outcome key
- om-0000
- arm key
- OG000
- arm label
- All Patients
- regimen
- All subjects will receive: 1. Capecitabine (oral 5-Fluorouracil) 1500mg/m2 orally per day (divided into two doses with maximum daily dose of 2500mg) on days 1 through 14. 2. Temozolomide (second generation alkylating agent) 150 to 200 mg/m2 orally on days 10 through 14. After completion of 6 cycles, patients achieving a complete or partial tumor response may continue to receive capecitabine temozolomide at the investigator's discretion in the absence of disease progression or unacceptable toxicity. Patients will be monitored for six months after they come off the study (either after completing 6 cycles or in setting of disease progression or unacceptable toxicity). Capecitabine: 1500mg/m2 orally per day (divided into two doses with maximum daily dose of 2500mg) on days 1 through 14. Temozolomide: 150 to 200 mg/m2 orally on days 10 through 14.
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03930771-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-adenoma
- nct id
- NCT03930771
- outcome key
- om-0001
- arm key
- OG000
- arm label
- All Patients
- regimen
- All subjects will receive: 1. Capecitabine (oral 5-Fluorouracil) 1500mg/m2 orally per day (divided into two doses with maximum daily dose of 2500mg) on days 1 through 14. 2. Temozolomide (second generation alkylating agent) 150 to 200 mg/m2 orally on days 10 through 14. After completion of 6 cycles, patients achieving a complete or partial tumor response may continue to receive capecitabine temozolomide at the investigator's discretion in the absence of disease progression or unacceptable toxicity. Patients will be monitored for six months after they come off the study (either after completing 6 cycles or in setting of disease progression or unacceptable toxicity). Capecitabine: 1500mg/m2 orally per day (divided into two doses with maximum daily dose of 2500mg) on days 1 through 14. Temozolomide: 150 to 200 mg/m2 orally on days 10 through 14.
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03930771-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-adenoma
- nct id
- NCT03930771
- outcome key
- om-0002
- arm key
- OG000
- arm label
- All Patients
- regimen
- All subjects will receive: 1. Capecitabine (oral 5-Fluorouracil) 1500mg/m2 orally per day (divided into two doses with maximum daily dose of 2500mg) on days 1 through 14. 2. Temozolomide (second generation alkylating agent) 150 to 200 mg/m2 orally on days 10 through 14. After completion of 6 cycles, patients achieving a complete or partial tumor response may continue to receive capecitabine temozolomide at the investigator's discretion in the absence of disease progression or unacceptable toxicity. Patients will be monitored for six months after they come off the study (either after completing 6 cycles or in setting of disease progression or unacceptable toxicity). Capecitabine: 1500mg/m2 orally per day (divided into two doses with maximum daily dose of 2500mg) on days 1 through 14. Temozolomide: 150 to 200 mg/m2 orally on days 10 through 14.
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03930771-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-adenoma
- nct id
- NCT03930771
- outcome key
- om-0003
- arm key
- OG000
- arm label
- All Patients
- regimen
- All subjects will receive: 1. Capecitabine (oral 5-Fluorouracil) 1500mg/m2 orally per day (divided into two doses with maximum daily dose of 2500mg) on days 1 through 14. 2. Temozolomide (second generation alkylating agent) 150 to 200 mg/m2 orally on days 10 through 14. After completion of 6 cycles, patients achieving a complete or partial tumor response may continue to receive capecitabine temozolomide at the investigator's discretion in the absence of disease progression or unacceptable toxicity. Patients will be monitored for six months after they come off the study (either after completing 6 cycles or in setting of disease progression or unacceptable toxicity). Capecitabine: 1500mg/m2 orally per day (divided into two doses with maximum daily dose of 2500mg) on days 1 through 14. Temozolomide: 150 to 200 mg/m2 orally on days 10 through 14.
- analyzed count
- 1
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03930771-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-adenoma
- nct id
- NCT03930771
- outcome key
- om-0004
- arm key
- OG000
- arm label
- All Patients
- regimen
- All subjects will receive: 1. Capecitabine (oral 5-Fluorouracil) 1500mg/m2 orally per day (divided into two doses with maximum daily dose of 2500mg) on days 1 through 14. 2. Temozolomide (second generation alkylating agent) 150 to 200 mg/m2 orally on days 10 through 14. After completion of 6 cycles, patients achieving a complete or partial tumor response may continue to receive capecitabine temozolomide at the investigator's discretion in the absence of disease progression or unacceptable toxicity. Patients will be monitored for six months after they come off the study (either after completing 6 cycles or in setting of disease progression or unacceptable toxicity). Capecitabine: 1500mg/m2 orally per day (divided into two doses with maximum daily dose of 2500mg) on days 1 through 14. Temozolomide: 150 to 200 mg/m2 orally on days 10 through 14.
- analyzed count
- 0
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03930771-om-0004#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-adenoma
- nct id
- NCT03930771
- harm key
- EG000
- source section id
- NCT03930771-ae
- event group key
- EG000
- event group label
- All Patients
- serious affected
- 0
- serious at risk
- 1
- other affected
- 1
- other at risk
- 1
- frequency threshold
- 0
- collection period
- Adverse events were monitored from the time of consent through six months after completion of the study.
- event definition
- Source null
- 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
- setting source links
Preserved source evidence · Not medical advice