Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Colorectal Cancer and Resectable Metastases
Essai De Phase III De Chimiotherapie Par FOLFOX 4 Ou Par Une Succession FOLFOX 7 - FOLFIRI Chez Des Patients Ayant Des Metastases Resecables D'Origine Colorectale - MIROX
NCT00268398CI-TRIAL-00006963MIROXcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating patients with colorectal cancer and resectable metastases.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| oxaliplatin, folinic acid, fluorouracil | Drug | — | UNRESOLVED |
| oxaliplatin, irinotecan, folinic acid, fluorouracil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- FOLFOX4
- interventionNames
- Drug: oxaliplatin, folinic acid, fluorouracil
- type
- EXPERIMENTAL
- label
- FOLFOX7 followed by FOLFIRI
- interventionNames
- Drug: oxaliplatin, irinotecan, folinic acid, fluorouracil
Primary outcomes (1)
- measure
- disease-free survival
- timeFrame
- 2-year
Secondary outcomes (4)
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
MAIN ELIGIBILITY CRITERIA DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the colon or rectum * Resectable or resected metastatic disease, PATIENT CHARACTERISTICS: * WHO performance status 0-2 * Alkaline phosphatase ≤ 5 times upper limit of normal (ULN) * Bilirubin ≤ 2 times normal * Creatinine ≤ 135 mmol/L or creatinine clearance ≥ 60 mL/min * SGOT and SGPT ≤ 3 times ULN * No peripheral neuropathy that affects normal functions * No unresolved complications from prior surgery PRIOR CONCURRENT THERAPY: * At least 1 year since prior FOLFOX 4 or FOLFIRI regimen in the adjuvant setting * No concurrent participation in another clinical trial * Recovered from prior therapy
References
Publications (2)
- DERIVEDHamidou Z, Chibaudel B, Hebbar M, Hug de Larauze M, Andre T, Louvet C, Brusquant D, Garcia-Larnicol ML, de Gramont A, Bonnetain F. Time to Definitive Health-Related Quality of Life Score Deterioration in Patients with Resectable Metastatic Colorectal Cancer Treated with FOLFOX4 versus Sequential Dose-Dense FOLFOX7 followed by FOLFIRI: The MIROX Randomized Phase III Trial. PLoS One. 2016 Jun 16;11(6):e0157067. doi: 10.1371/journal.pone.0157067. eCollection 2016. PMID 27310205
- DERIVEDHebbar M, Chibaudel B, Andre T, Mineur L, Smith D, Louvet C, Dutel JL, Ychou M, Legoux JL, Mabro M, Faroux R, Auby D, Brusquant D, Khalil A, Truant S, Hadengue A, Dalban C, Gayet B, Paye F, Pruvot FR, Bonnetain F, Landi B, Flesch M, Carola E, Martin P, Vaillant E, de Gramont A; Group Cooperateur Multidisciplinaire en Oncologie (GERCOR) Group. FOLFOX4 versus sequential dose-dense FOLFOX7 followed by FOLFIRI in patients with resectable metastatic colorectal cancer (MIROX): a pragmatic approach to chemotherapy timing with perioperative or postoperative chemotherapy from an open-label, randomized phase III trial. Ann Oncol. 2015 Feb;26(2):340-7. doi: 10.1093/annonc/mdu539. Epub 2014 Nov 17. PMID 25403578