TriangleNCT01208103 · STUDY IN CONTEXT
Bevacizumab, Capecitabine, and Oxaliplatin in Treating Advanced Small Intestinal or Ampulla of Vater Adenocarcinoma
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
A Bayesian sequential monitoring design will be used. PFS will be estimated using the Kaplan-Meier method.The length of time interval in months from date of first treatment, during and after the treatment a participant lives without progression.
Complete response + Partial response using RECIST 1.1 (Response Evaluation Criteria in Solid Tumor)
Time interval in months from date of first treatment until the date of first documented progression
The length of time interval in months from date of first treatment until the date of death or lost follow-up
Toxicity was graded according to the NCI Common terminology Criteria for Adverse Events (CTCAE) 4.0 except for neurosensory and skin toxicity. Neurosensory toxicity was graded according to the Neurologic Toxicity Scale for Oxaliplatin Dose Adjustments.
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-malignant-ampulla-of-vater-neoplasm
- nct id
- NCT01208103
- trial label
- Bevacizumab, Capecitabine, and Oxaliplatin in Treating Advanced Small Intestinal or Ampulla of Vater Adenocarcinoma
- 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-malignant-ampulla-of-vater-neoplasm
- nct id
- NCT01208103
- outcome key
- om-0000
- source section id
- NCT01208103-om-0000
- source outcome index
- 0
- endpoint
- Number of Participants With Progression-free Survival (PFS) at Six Months
- endpoint definition
- A Bayesian sequential monitoring design will be used. PFS will be estimated using the Kaplan-Meier method.The length of time interval in months from date of first treatment, during and after the treatment a participant lives without progression.
- 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-malignant-ampulla-of-vater-neoplasm
- nct id
- NCT01208103
- outcome key
- om-0001
- source section id
- NCT01208103-om-0001
- source outcome index
- 1
- endpoint
- To Determine the Response Rate (RR) for CAPOX and Bevacizumab
- endpoint definition
- Complete response + Partial response using RECIST 1.1 (Response Evaluation Criteria in Solid Tumor)
- time origin
- 39 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-malignant-ampulla-of-vater-neoplasm
- nct id
- NCT01208103
- outcome key
- om-0002
- source section id
- NCT01208103-om-0002
- source outcome index
- 2
- endpoint
- To Determine the Overall PFS for CAPOX and Bevacizumab
- endpoint definition
- Time interval in months from date of first treatment until the date of first documented progression
- time origin
- 39 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-malignant-ampulla-of-vater-neoplasm
- nct id
- NCT01208103
- outcome key
- om-0003
- source section id
- NCT01208103-om-0003
- source outcome index
- 3
- endpoint
- To Determine the Overall Survival (OS) for CAPOX and Bevacizumab
- endpoint definition
- The length of time interval in months from date of first treatment until the date of death or lost follow-up
- time origin
- 39 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-malignant-ampulla-of-vater-neoplasm
- nct id
- NCT01208103
- outcome key
- om-0004
- source section id
- NCT01208103-om-0004
- source outcome index
- 4
- endpoint
- Number of Participants With Adverse Events
- endpoint definition
- Toxicity was graded according to the NCI Common terminology Criteria for Adverse Events (CTCAE) 4.0 except for neurosensory and skin toxicity. Neurosensory toxicity was graded according to the Neurologic Toxicity Scale for Oxaliplatin Dose Adjustments.
- time origin
- 39 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
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-ampulla-of-vater-neoplasm
- nct id
- NCT01208103
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Bevacizumab + Capecitabine + Oxaliplatin
- regimen
- Capecitabine 750mg/m2 oral twice daily, Days 1 - 14 and Panitumumab 9 mg/kg IV over 60 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle.
- analyzed count
- 30
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01208103-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-ampulla-of-vater-neoplasm
- nct id
- NCT01208103
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Bevacizumab + Capecitabine + Oxaliplatin
- regimen
- Capecitabine 750mg/m2 oral twice daily, Days 1 - 14 and Bevacizumab 7.5 mg/kg IV over 90 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle.
- analyzed count
- 30
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01208103-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-ampulla-of-vater-neoplasm
- nct id
- NCT01208103
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Bevacizumab + Capecitabine + Oxaliplatin
- regimen
- Capecitabine 750mg/m2 oral twice daily, Days 1 - 14 and Bevacizumab 7.5 mg/kg IV over 90 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle.
- analyzed count
- 30
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01208103-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-ampulla-of-vater-neoplasm
- nct id
- NCT01208103
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Bevacizumab + Capecitabine + Oxaliplatin
- regimen
- Capecitabine 750mg/m2 oral twice daily, Days 1 - 14 and Bevacizumab 7.5 mg/kg IV over 90 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle.
- analyzed count
- 30
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01208103-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-ampulla-of-vater-neoplasm
- nct id
- NCT01208103
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Bevacizumab + Capecitabine + Oxaliplatin
- regimen
- Capecitabine 750mg/m2 oral twice daily, Days 1 - 14 and Bevacizumab 7.5 mg/kg IV over 90 minutes on Day 1 and Oxaliplatin 130 mg/m2 IV over 2 hours Day 1 of 21-day cycle.
- analyzed count
- 30
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT01208103-om-0004#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-malignant-ampulla-of-vater-neoplasm
- nct id
- NCT01208103
- harm key
- EG000
- source section id
- NCT01208103-ae
- event group key
- EG000
- event group label
- Bevacizumab + Capecitabine + Oxaliplatin
- serious affected
- 4
- serious at risk
- 30
- other affected
- 30
- other at risk
- 30
- frequency threshold
- 3.3
- collection period
- Assessed up to 67 months
- 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