Comparison · NCT00807911-3ffca0da
Adjuvant Fluorouracil +Leucovorin vs Adjuvant FOLFOX: Number of Participants With Disease Recurrence With Pathological Stage III
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Adjuvant Fluorouracil +Leucovorin vs Adjuvant FOLFOX: Number of Participants With Disease Recurrence With Pathological Stage III. Trial comparisons, record NCT00807911-3ffca0da. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00807911-3ffca0da
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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 | 0.396 | 0.304 | 0.496 | wilson | |
| Risk in group 2 | 0.284 | 0.206 | 0.378 | wilson | |
| Risk difference, group 1 minus group 2 | 0.112 | -0.0201 | 0.239 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.39 | 0.938 | 2.07 | log | |
| Odds ratio, group 1 over group 2 | 1.65 | 0.911 | 2.99 | log | |
| Number needed to treat, for one more participant with the outcome on Adjuvant Fluorouracil +Leucovorin than on Adjuvant FOLFOX | 8.97 | 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 | Adjuvant Fluorouracil +Leucovorin | FL (5-FU 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles)~Adjuvant FL: 5-Fluorouracil 380 mg/m2, leucovorin 20 mg/m2 on D1-5 q 4 weeks X 4 cycles | 38 | 96 | OG000 |
| Group 2 | Adjuvant FOLFOX | FOLFOX (oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 on D1, 5-FU bolus 400 mg/m2 on D1, 5-FU infusion 2400 mg/m2 for 46 hours q 2 weeks X 8 cycles)~Adjuvant FOLFOX: oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 on D1, 5-Fluorouracil bolus 400 mg/m2 on D1, 5-Fluorouracil continuous infusion 2400 mg/m2 for 46 hours q 2 weeks X 8 cycles | 29 | 102 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Disease Recurrence With Pathological Stage III
- Description
Disease-free survival will be measured as the time from the date of randomization to the date of disease relapse or death due to any cause. Using Cox-proportional hazard regression, the hazard ratio together with the 95% confidence interval will be reported, in addition to Kaplan-Meier estimates of the survival curves, including medians and rates with 95% confidence intervals. Intent-to-treat population included all randomised patients, and per-protocol population included patients who received at least 1 dose of chemotherapy without any violation of inclusion criteria.
- Time frame
- up to 3 years after completion of treatment
- Population
- Among intention-to-treat population (all randomised patients), Patients with pathological stage III disease
Source ClinicalTrials.gov
Trial
- Title
- Adjuvant Chemotherapy After Preoperative Chemoradiotherapy to Treat Rectal Cancer
- NCT number
- NCT00807911
- Phases
- PHASE2
- Conditions
- Rectal Cancer
- Interventions
- Adjuvant FL, Adjuvant FOLFOX
- Lead sponsor
- Asan Medical Center
- Results first posted
- 2024-10-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00807911?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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