TriangleNCT02595424 · STUDY IN CONTEXT
Cisplatin and Etoposide Versus Temozolomide and Capecitabine in Patients With Advanced Poorly Differentiated (G3) Non-Small Cell Gastrointestinal Neuroendocrine Carcinomas
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
The impact of each treatment regimen on objective response rate (ORR, defined as above in the secondary objective) are assessed by Ki-67 index level as an exploratory analysis. Using Youden's index, which considers specificity and sensitivity equally important, the optimal cutoff point of Ki-67 index to best predict response is 50.5. Using the optimal Ki-67 cutoff value of 50.5 from the ROC analysis, patients were divided into Ki-67 low (Ki-67 \< 50.5) and high (Ki-67 ≥ 50.5) groups. The impact of each treatment regimen on ORR was explored in Ki-67 low and Ki-67 high separately.
The impact of each treatment regimen on PFS and OS (defined as above in the primary and secondary objectives) are assessed by Ki-67 index level as an exploratory analysis. Using Youden's index, which considers specificity and sensitivity equally important, the optimal cutoff point of Ki-67 index to best predict response is 50.5. Using the optimal Ki-67 cutoff value of 50.5 from the ROC analysis, patients were divided into Ki-67 low (Ki-67 \< 50.5) and high (Ki-67 ≥ 50.5) groups. The impact of each treatment regimen on PFS and OS were explored in Ki-67 low and Ki-67 high separately.
The association between tumor differentiation (well differentiated versus poorly differentiated) with PFS, ORR and OS (defined as in the primary and secondary objectives) were evaluated.
PFS is defined as the time from randomization to documented progression or death without progression. PFS is censored at the date of last disease evaluation. The study was closed for futility in 2021 after the 2021 Spring DSMC meeting, which found that the boundary for futility had been met (ie, temozolomide and capecitabine did not appear to be superior to platinum and etoposide chemotherapy). As the interim analysis finding led to the conclusion of the study, no PFS stratified logrank test was conducted with the data extracted on April 23rd, 2025 for the final analysis, that was presented here.
OS is defined as the time from randomization to death from any cause. OS is censored at the date of last contact. Median OS is estimated using the Kaplan-Meier method.
ORR is defined as the proportion of patients with complete response (CR) or partial response (PR). Response is evaluated using the RECIST 1.1 criteria. CR is defined as disappearance of all lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
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-intestinal-neoplasm
- nct id
- NCT02595424
- trial label
- Cisplatin and Etoposide Versus Temozolomide and Capecitabine in Patients With Advanced Poorly Differentiated (G3) Non-Small Cell Gastrointestinal Neuroendocrine Carcinomas
- 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
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-intestinal-neoplasm
- nct id
- NCT02595424
- outcome key
- om-0003
- source section id
- NCT02595424-om-0003
- source outcome index
- 3
- endpoint
- To Assess the Objective Response Rate Based on Marker of Proliferation Ki-67 Index
- endpoint definition
- The impact of each treatment regimen on objective response rate (ORR, defined as above in the secondary objective) are assessed by Ki-67 index level as an exploratory analysis. Using Youden's index, which considers specificity and sensitivity equally important, the optimal cutoff point of Ki-67 index to best predict response is 50.5. Using the optimal Ki-67 cutoff value of 50.5 from the ROC analysis, patients were divided into Ki-67 low (Ki-67 \< 50.5) and high (Ki-67 ≥ 50.5) groups. The impact of each treatment regimen on ORR was explored in Ki-67 low and Ki-67 high separately.
- time origin
- assessed at baseline, every 8 weeks until treatment completion, then every 3 months within 2 years and every 6 months within 3-5 years, up to 5 years from registration; the best response among all assessments was considered as objective response
- analysis role
- exploratory
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Eligible patients with Ki-67 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-intestinal-neoplasm
- nct id
- NCT02595424
- outcome key
- om-0004
- source section id
- NCT02595424-om-0004
- source outcome index
- 4
- endpoint
- To Assess the Treatment Effect Based on Marker of Proliferation Ki-67 Index
- endpoint definition
- The impact of each treatment regimen on PFS and OS (defined as above in the primary and secondary objectives) are assessed by Ki-67 index level as an exploratory analysis. Using Youden's index, which considers specificity and sensitivity equally important, the optimal cutoff point of Ki-67 index to best predict response is 50.5. Using the optimal Ki-67 cutoff value of 50.5 from the ROC analysis, patients were divided into Ki-67 low (Ki-67 \< 50.5) and high (Ki-67 ≥ 50.5) groups. The impact of each treatment regimen on PFS and OS were explored in Ki-67 low and Ki-67 high separately.
- time origin
- assessed at baseline, every 8 weeks until treatment completion, then every 3 months within 2 years and every 6 months within 3-5 years from randomization until disease progression, up to 5 years from study registration
- analysis role
- exploratory
- reporting status
- NOT_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-intestinal-neoplasm
- nct id
- NCT02595424
- outcome key
- om-0005
- source section id
- NCT02595424-om-0005
- source outcome index
- 5
- endpoint
- Association Between Tumor Differentiation and Treatment Effect
- endpoint definition
- The association between tumor differentiation (well differentiated versus poorly differentiated) with PFS, ORR and OS (defined as in the primary and secondary objectives) were evaluated.
- time origin
- assessed at baseline, every 8 weeks until treatment completion, then every 3 months within 2 years and every 6 months within 3-5 years from randomization until disease progression, up to 5 years from study registration
- analysis role
- exploratory
- reporting status
- NOT_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-intestinal-neoplasm
- nct id
- NCT02595424
- outcome key
- om-0000
- source section id
- NCT02595424-om-0000
- source outcome index
- 0
- endpoint
- Progression-free Survival (PFS)
- endpoint definition
- PFS is defined as the time from randomization to documented progression or death without progression. PFS is censored at the date of last disease evaluation. The study was closed for futility in 2021 after the 2021 Spring DSMC meeting, which found that the boundary for futility had been met (ie, temozolomide and capecitabine did not appear to be superior to platinum and etoposide chemotherapy). As the interim analysis finding led to the conclusion of the study, no PFS stratified logrank test was conducted with the data extracted on April 23rd, 2025 for the final analysis, that was presented here.
- time origin
- assessed at baseline, every 8 weeks until treatment completion, then every 3 months within 2 years and every 6 months within 3-5 years from randomization until disease progression, up to 5 years from study registration
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All 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-intestinal-neoplasm
- nct id
- NCT02595424
- outcome key
- om-0001
- source section id
- NCT02595424-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival (OS)
- endpoint definition
- OS is defined as the time from randomization to death from any cause. OS is censored at the date of last contact. Median OS is estimated using the Kaplan-Meier method.
- time origin
- assessed at baseline, then every 3 months within 2 years from randomization, and every 6 months if patient is 3-5 years from randomization, up to 5 years from randomization
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All 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-intestinal-neoplasm
- nct id
- NCT02595424
- outcome key
- om-0002
- source section id
- NCT02595424-om-0002
- source outcome index
- 2
- endpoint
- Objective Response Rate (ORR)
- endpoint definition
- ORR is defined as the proportion of patients with complete response (CR) or partial response (PR). Response is evaluated using the RECIST 1.1 criteria. CR is defined as disappearance of all lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
- time origin
- assessed at baseline, every 8 weeks until treatment completion, then every 3 months within 2 years and every 6 months within 3-5 years, up to 5 years from registration; the best response among all assessments was considered as objective response
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All eligible patients
- 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-intestinal-neoplasm
- nct id
- NCT02595424
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Arm A (Capecitabine, Temozolomide)
- regimen
- Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 31
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02595424-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-intestinal-neoplasm
- nct id
- NCT02595424
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Arm B (Cisplatin, Carboplatin, Etoposide)
- regimen
- Patients receive cisplatin IV on days 1-3 or carboplatin IV on day 1. Patients also receive etoposide IV on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 32
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02595424-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-intestinal-neoplasm
- nct id
- NCT02595424
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Arm A (Capecitabine, Temozolomide)
- regimen
- Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 31
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02595424-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-intestinal-neoplasm
- nct id
- NCT02595424
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Arm B (Cisplatin, Carboplatin, Etoposide)
- regimen
- Patients receive cisplatin IV on days 1-3 or carboplatin IV on day 1. Patients also receive etoposide IV on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 32
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02595424-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-intestinal-neoplasm
- nct id
- NCT02595424
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Arm A (Capecitabine, Temozolomide)
- regimen
- Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 31
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02595424-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-intestinal-neoplasm
- nct id
- NCT02595424
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Arm B (Cisplatin, Carboplatin, Etoposide)
- regimen
- Patients receive cisplatin IV on days 1-3 or carboplatin IV on day 1. Patients also receive etoposide IV on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- analyzed count
- 32
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02595424-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-intestinal-neoplasm
- nct id
- NCT02595424
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Arm A (Capecitabine, Temozolomide) -- Ki-67 Low
- regimen
- Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Laboratory Biomarker Analysis: Correlative studies Temozolomide: Given PO
- analyzed count
- 20
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02595424-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-intestinal-neoplasm
- nct id
- NCT02595424
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Arm B (Cisplatin, Carboplatin, Etoposide)--- Ki-67 Low
- regimen
- Patients receive cisplatin IV on days 1-3 or carboplatin IV on day 1. Patients also receive etoposide IV on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Etoposide: Given IV Laboratory Biomarker Analysis: Correlative studies
- analyzed count
- 14
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02595424-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-intestinal-neoplasm
- nct id
- NCT02595424
- outcome key
- om-0003
- arm key
- OG002
- arm label
- Arm A (Capecitabine, Temozolomide) -- Ki-67 High
- regimen
- Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO Laboratory Biomarker Analysis: Correlative studies Temozolomide: Given PO
- analyzed count
- 11
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02595424-om-0003#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-intestinal-neoplasm
- nct id
- NCT02595424
- outcome key
- om-0003
- arm key
- OG003
- arm label
- Arm B (Cisplatin, Carboplatin, Etoposide)--- Ki-67 High
- regimen
- Patients receive cisplatin IV on days 1-3 or carboplatin IV on day 1. Patients also receive etoposide IV on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV Etoposide: Given IV Laboratory Biomarker Analysis: Correlative studie
- analyzed count
- 18
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02595424-om-0003#groups/OG003
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-intestinal-neoplasm
- nct id
- NCT02595424
- harm key
- EG000
- source section id
- NCT02595424-ae
- event group key
- EG000
- event group label
- Arm A (Capecitabine, Temozolomide)
- serious affected
- 9
- serious at risk
- 28
- other affected
- 27
- other at risk
- 28
- frequency threshold
- 5
- collection period
- Assessed every cycle (1 cycle=21 days) while on treatment and for 30 days after the end of treatment, up to 5 years
- 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
- release id
- clinical-indications-draft-1
- disease state id
- ds-intestinal-neoplasm
- nct id
- NCT02595424
- harm key
- EG001
- source section id
- NCT02595424-ae
- event group key
- EG001
- event group label
- Arm B (Cisplatin, Carboplatin, Etoposide)
- serious affected
- 20
- serious at risk
- 29
- other affected
- 28
- other at risk
- 29
- frequency threshold
- 5
- collection period
- Assessed every cycle (1 cycle=21 days) while on treatment and for 30 days after the end of treatment, up to 5 years
- 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