Combination Chemotherapy in Treating Patients With Colorectal Cancer and Resectable Metastases

NCT00268398 | Completed Phase 3

• 5 other identifiers: CDR0000453815GERCOR-C02-1GERCOR-C02-1-MIROXEU-20567SANOFI-GERCOR-C02-1
• Study Type: interventional
• Target: 284
• Locations: 1 country
• Sites: 32

Brief Summary

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

Colorectal Cancer; Metastatic Cancer; Chemotherapy

Keywords

adenocarcinoma of the colon; stage IV colon cancer; adenocarcinoma of the rectum; stage IV rectal cancer; resectable metastases

Outcome Measures

Primary Outcomes (1)

• disease-free survival

  2-year

Secondary Outcomes (4)

• Overall survival

  2-year, 3-year, 5-year

• Tolerability

  2-year

• Quality of life

  2-year

• Pharmacogenetics

  2-year

Study Arms (2)

FOLFOX4

ACTIVE COMPARATOR

Drug: oxaliplatin, folinic acid, fluorouracil

FOLFOX7 followed by FOLFIRI

EXPERIMENTAL

Drug: oxaliplatin, irinotecan, folinic acid, fluorouracil

Interventions

oxaliplatin, folinic acid, fluorouracil DRUG

folinic acid 200 mg/m² (day 1\&2) oxaliplatin 85 mg/m² (day 1) bolus 5FU 400 mg/m² (day 1\&2) continuous 5FU 600mg/m² (day 1 to 2)

FOLFOX4

oxaliplatin, irinotecan, folinic acid, fluorouracil DRUG

FOLFOX7 folinic acid 400 mg/m² (day 1) oxaliplatin 130 mg/m² (day 1) continuous 5FU 3000mg/m² (day 1 to 2) FOLFIRI folinic acid 400 mg/m² (day 1) irinotecan 180 mg/m² (day 1) bolus 5FU 400 mg/m² (day 1) continuous 5FU 2400mg/m² (day 1 to 2)

FOLFOX7 followed by FOLFIRI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• GERCOR - Multidisciplinary Oncology Cooperative Group: lead

Study Sites (32)

Institut Sainte Catherine

Avignon, 84000, France

Location

Hopital Duffaut

Avignon, 84902, France

Location

C.H.G. Beauvais

Beauvais, 60021, France

Location

Hopital Saint Andre

Bordeaux, 33075, France

Location

Hopital Ambroise Pare

Boulogne-Billancourt, F-92104, France

Location

Centre Hospitalier Docteur Duchenne

Boulogne-sur-Mer, 62200, France

Location

Centre Hospitalier de Briey

Briey, 54151, France

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Hopital Louis Pasteur

Chartres, 28018, France

Location

Hopital Beaujon

Clichy, 92118, France

Location

Louis Mourier Hospital

Colombes, 92701, France

Location

Clinique du Parc

Croix, 59170, France

Location

Hopital Drevon

Dijon, 21000, France

Location

Centre Hospitalier Departemental

La Roche-sur-Yon, F-85025, France

Location

Hopital Saint - Louis

La Rochelle, 17000, France

Location

Hopital Robert Boulin

Libourne, 33500, France

Location

Polyclinique Du Bois

Lille, 59000, France

Location

Centre Hospital Universitaire Hop Huriez

Lille, 59037, France

Location

Polyclinique des Quatre Pavillons

Lormont, 33310, France

Location

Hopital Saint Joseph

Marseille, 13008, France

Location

Hopital Notre-Dame de Bon Secours

Metz, 57038, France

Location

Centre Hospitalier Intercommunal Le Raincy - Montfermeil

Montfermeil, 93370, France

Location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

Hopital Saint Antoine

Paris, 75571, France

Location

CHU Pitie-Salpetriere

Paris, 75651, France

Location

Hopital Tenon

Paris, 75970, France

Location

Hopital Haut Leveque

Pessac, 33604, France

Location

Polyclinique De Courlancy

Reims, F-51100, France

Location

Clinique Specialise du Littoral-Cote d'Opale

Saint-Martin-Boulogne, 62280, France

Location

Clinique Charcot

Sainte-Foy-lès-Lyon, 69110, France

Location

C.H. Senlis

Senlis, 60309, France

Location

Hopital Foch

Suresnes, 92151, France

Location

Related Publications (2)

• Hamidou 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 DERIVED

• Hebbar 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 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis; Colonic Neoplasms; Rectal Neoplasms

Interventions

Oxaliplatin; Leucovorin; Fluorouracil; Irinotecan

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Camptothecin; Alkaloids

Study Officials

• Mohamed Hebbar, MD

  Centre Hospital Universitaire Hop Huriez

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2005
• First Posted: December 22, 2005
• Study Start: July 1, 2002
• Primary Completion: December 1, 2011
• Last Updated: May 22, 2012

Record last verified: 2012-05

Locations

FR (32)