Comparison · NCT00457691-ab73cf40
FOLFIRI + Sunitinib vs FOLFIRI + Placebo: Number of Participants With Overall Confirmed Objective Response
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. FOLFIRI + Sunitinib vs FOLFIRI + Placebo: Number of Participants With Overall Confirmed Objective Response. Trial comparisons, record NCT00457691-ab73cf40. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00457691-ab73cf40
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.321 | 0.277 | 0.369 | wilson | |
| Risk in group 2 | 0.335 | 0.29 | 0.384 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0138 | -0.0799 | 0.0524 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.959 | 0.783 | 1.17 | log | |
| Odds ratio, group 1 over group 2 | 0.939 | 0.695 | 1.27 | log | |
| Number needed to treat, for one fewer participant with the outcome on FOLFIRI + Sunitinib than on FOLFIRI + Placebo | 72.3 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | FOLFIRI + Sunitinib | Intravenous (IV) irinotecan (180 milligrams per square meter \[mg/m²\]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle. | 124 | 386 | OG000 |
| Group 2 | FOLFIRI + Placebo | IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle. | 128 | 382 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Overall Confirmed Objective Response
- Description
Objective disease response: participants with a confirmed complete response (CR) or partial response (PR) according to the Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
- Time frame
- Day 28 of Cycle 1 up to 30 months
- Population
Source ClinicalTrials.gov
Trial
- Title
- Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal Cancer
- NCT number
- NCT00457691
- Phases
- PHASE3
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- 5 fluorouracil, irinotecan, levo- leucovorin, sunitinib, 5 fluorouracil, irinotecan, levo- leucovorin, placebo
- Lead sponsor
- Pfizer
- Results first posted
- 2011-06-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00457691?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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