TriangleNCT00433550 · STUDY IN CONTEXT
Irinotecan, Oxaliplatin, and Capecitabine as First-Line Therapy in Treating Patients With Metastatic or Unresectable Locally Advanced Small Bowel Cancer
Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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
Evaluated using RECIST version 1.0. Confirmed tumor response rate was defined as achieving partial response (PR) or complete response (CR) in two consecutive assessments at least 6 weeks apart. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. The confirmed response rate is reported as the number of participants with confirmed responses divided by the number of evaluated participants.
Overall survival will be defined as the time from registration to death. Patients lost to follow-up for this endpoint will be censored at the date of last contact (i.e., last known alive). The distribution of overall survival will be estimated using Kaplan-Meier methodology.
Time to disease progression is defined as the time from registration to the earlier of documentation of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The distribution of time to progression will be estimated using Kaplan-Meier methodology.
Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented. Duration of response will be analyzed using Kaplan-Meier methods.
Time to treatment failure is defined to be the time from the date of registration to the date at which the patient is removed from treatment due to progression, toxicity, or refusal. If the patient is considered to have had a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they are removed from treatment. Time to treatment failure will be analyzed using Kaplan-Meier methods.
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-small-intestine-cancer-recurrent-32754d2e
- nct id
- NCT00433550
- trial label
- Irinotecan, Oxaliplatin, and Capecitabine as First-Line Therapy in Treating Patients With Metastatic or Unresectable Locally Advanced Small Bowel Cancer
- applicability
- unclear
- applicability note
- Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- 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
- 3
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-small-intestine-cancer-recurrent-32754d2e
- nct id
- NCT00433550
- outcome key
- om-0000
- source section id
- NCT00433550-om-0000
- source outcome index
- 0
- endpoint
- Confirmed Tumor Response Rate (Proportion of Participants With Complete Response)
- endpoint definition
- Evaluated using RECIST version 1.0. Confirmed tumor response rate was defined as achieving partial response (PR) or complete response (CR) in two consecutive assessments at least 6 weeks apart. CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. The confirmed response rate is reported as the number of participants with confirmed responses divided by the number of evaluated participants.
- time origin
- 36 weeks
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- One patient was later found to be a major treatment violation during cycle 1 and was not included in this analysis. All the other 32 patients were analyzed together for this endpoint.
- 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-small-intestine-cancer-recurrent-32754d2e
- nct id
- NCT00433550
- outcome key
- om-0001
- source section id
- NCT00433550-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival
- endpoint definition
- Overall survival will be defined as the time from registration to death. Patients lost to follow-up for this endpoint will be censored at the date of last contact (i.e., last known alive). The distribution of overall survival will be estimated using Kaplan-Meier methodology.
- time origin
- Up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- One patient was later found to be a major treatment violation during cycle 1 and was not included in this analysis. All the other 32 patients were analyzed together for this endpoint.
- 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-small-intestine-cancer-recurrent-32754d2e
- nct id
- NCT00433550
- outcome key
- om-0002
- source section id
- NCT00433550-om-0002
- source outcome index
- 2
- endpoint
- Progression Free Survival
- endpoint definition
- Time to disease progression is defined as the time from registration to the earlier of documentation of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The distribution of time to progression will be estimated using Kaplan-Meier methodology.
- time origin
- Up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- One patient was later found to be a major treatment violation during cycle 1 and was not included in this analysis. All the other 32 patients were analyzed together for this endpoint.
- 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-small-intestine-cancer-recurrent-32754d2e
- nct id
- NCT00433550
- outcome key
- om-0003
- source section id
- NCT00433550-om-0003
- source outcome index
- 3
- endpoint
- Duration of Response
- endpoint definition
- Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a CR or PR to the date progression is documented. Duration of response will be analyzed using Kaplan-Meier methods.
- time origin
- Up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- All patients who achieved a CR or PR are included in this analysis.
- 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-small-intestine-cancer-recurrent-32754d2e
- nct id
- NCT00433550
- outcome key
- om-0004
- source section id
- NCT00433550-om-0004
- source outcome index
- 4
- endpoint
- Time to Treatment Failure
- endpoint definition
- Time to treatment failure is defined to be the time from the date of registration to the date at which the patient is removed from treatment due to progression, toxicity, or refusal. If the patient is considered to have had a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they are removed from treatment. Time to treatment failure will be analyzed using Kaplan-Meier methods.
- time origin
- Up to 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- One patient was later found to be a major treatment violation during cycle 1 and was not included in this analysis. All the other 32 patients were analyzed together for this endpoint.
- 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-small-intestine-cancer-recurrent-32754d2e
- nct id
- NCT00433550
- outcome key
- om-0000
- arm key
- OG000
- arm label
- All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype)
- regimen
- Group 1 (6/6 UGT1A1 genotype): Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m\^2/day capecitabine PO BID on days 2-15 Group 2 (6/7 UGT1A1 genotype): Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15. Group 3 (7/7 UGT1A1 genotype): Patients receive 75 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15
- analyzed count
- 32
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00433550-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-small-intestine-cancer-recurrent-32754d2e
- nct id
- NCT00433550
- outcome key
- om-0001
- arm key
- OG000
- arm label
- All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype)
- regimen
- Group 1 (6/6 UGT1A1 genotype):\> Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m\^2/day capecitabine PO BID on days 2-15\> \> Group 2 (6/7 UGT1A1 genotype):\> Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15.\> \> Group 3 (7/7 UGT1A1 genotype):\> Patients receive 75 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15
- analyzed count
- 32
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00433550-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-small-intestine-cancer-recurrent-32754d2e
- nct id
- NCT00433550
- outcome key
- om-0002
- arm key
- OG000
- arm label
- All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype)
- regimen
- Group 1 (6/6 UGT1A1 genotype): \> Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m\^2/day capecitabine PO BID on days 2-15 \> \> Group 2 (6/7 UGT1A1 genotype): \> Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15. \> \> Group 3 (7/7 UGT1A1 genotype): \> Patients receive 75 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15
- analyzed count
- 32
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00433550-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-small-intestine-cancer-recurrent-32754d2e
- nct id
- NCT00433550
- outcome key
- om-0003
- arm key
- OG000
- arm label
- All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype)
- regimen
- Group 1 (6/6 UGT1A1 genotype):\> Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m\^2/day capecitabine PO BID on days 2-15\> \> Group 2 (6/7 UGT1A1 genotype):\> Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15.\> \> Group 3 (7/7 UGT1A1 genotype):\> Patients receive 75 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15
- analyzed count
- 12
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00433550-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-small-intestine-cancer-recurrent-32754d2e
- nct id
- NCT00433550
- outcome key
- om-0004
- arm key
- OG000
- arm label
- All Patients (6/6, 6/7, 7/7 UGT1A1 Genotype)
- regimen
- Group 1 (6/6 UGT1A1 genotype):\> Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 100 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 1600 mg/m\^2/day capecitabine PO BID on days 2-15\> \> Group 2 (6/7 UGT1A1 genotype):\> Patients receive 150 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15.\> \> Group 3 (7/7 UGT1A1 genotype):\> Patients receive 75 mg/m\^2 irinotecan hydrochloride IV over 90 minutes and 85 mg/m\^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 400 mg/m\^2/day capecitabine PO BID on days 2-15
- analyzed count
- 32
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00433550-om-0004#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-small-intestine-cancer-recurrent-32754d2e
- nct id
- NCT00433550
- harm key
- EG000
- source section id
- NCT00433550-ae
- event group key
- EG000
- event group label
- Group 1 (6/6 UGT1A1 Genotype)
- serious affected
- 7
- serious at risk
- 17
- other affected
- 16
- other at risk
- 17
- frequency threshold
- 0
- collection period
- Source null
- 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-small-intestine-cancer-recurrent-32754d2e
- nct id
- NCT00433550
- harm key
- EG001
- source section id
- NCT00433550-ae
- event group key
- EG001
- event group label
- Group 2 (6/7 UGT1A1 Genotype)
- serious affected
- 6
- serious at risk
- 10
- other affected
- 10
- other at risk
- 10
- frequency threshold
- 0
- collection period
- Source null
- 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-small-intestine-cancer-recurrent-32754d2e
- nct id
- NCT00433550
- harm key
- EG002
- source section id
- NCT00433550-ae
- event group key
- EG002
- event group label
- Group 3 (7/7 UGT1A1 Genotype)
- serious affected
- 1
- serious at risk
- 6
- other affected
- 6
- other at risk
- 6
- frequency threshold
- 0
- collection period
- Source null
- 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