Combination Chemotherapy in Treating Patients With Colorectal Cancer and Resectable Metastases
NCT ID: NCT00268398
Last Updated: 2012-05-22
Study Results
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Basic Information
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COMPLETED
PHASE3
284 participants
INTERVENTIONAL
2002-07-31
Brief Summary
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Detailed Description
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Primary
* Compare the 2-year disease-free survival rate in patients treated with these regimens.
Secondary
* Compare the overall survival of patients treated with these regimens.
* Compare the tolerability of these regimens in these patients.
* Compare the quality of life of patients treated with these regimens.
* Compare the objective response rate, postoperative complication rate, and transfusing rate in patients having metastasis surgery,
* Determine the pharmacogenetics of these regimens in these patients.
OUTLINE: This is a randomized, open-label, multicenter phase III study. Patients are stratified according to prior chemotherapy (perioperative vs postoperative), prior treatment (surgery only vs radiotherapy with or without surgery), and Blumgart score (0-1 vs 2-3 vs 4-5). Patients are randomized to 1 of 2 treatment arms.
* Arm I (FOLFOX 4): Patients receive FOLFOX 4 combination chemotherapy comprising oxaliplatin 85mg/m² IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV bolus /15min and fluorouracil continuously over 22 hours on day 1. Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.
* Arm II (FOLFOX 7 and FOLFIRI): Patients receive FOLFOX 7 combination chemotherapy comprising high-dose oxaliplatin 130mg/m² IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive FOLFIRI combination chemotherapy comprising irinotecan hydrochloride 180mg/m² IV over 30-90 minutes and leucovorin calcium and fluorouracil IV bolus /15min on day 1, and fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients in both arms who have undergone prior resection of metastatic lesions may undergo surgery after 6 courses of chemotherapy or after chemotherapy is completed.
Quality of life is assessed at baseline and after courses 4, 8, and 12.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 284 patients will be accrued for this study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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FOLFOX4
oxaliplatin, folinic acid, fluorouracil
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)
FOLFOX7 followed by FOLFIRI
oxaliplatin, irinotecan, folinic acid, fluorouracil
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)
Interventions
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oxaliplatin, folinic acid, fluorouracil
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)
oxaliplatin, irinotecan, folinic acid, fluorouracil
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)
Eligibility Criteria
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Inclusion 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
18 Years
75 Years
ALL
No
Sponsors
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GERCOR - Multidisciplinary Oncology Cooperative Group
OTHER
Responsible Party
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Principal Investigators
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Mohamed Hebbar, MD
Role: STUDY_CHAIR
Centre Hospital Universitaire Hop Huriez
Locations
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Institut Sainte Catherine
Avignon, , France
Hopital Duffaut
Avignon, , France
C.H.G. Beauvais
Beauvais, , France
Hopital Saint Andre
Bordeaux, , France
Hopital Ambroise Pare
Boulogne-Billancourt, , France
Centre Hospitalier Docteur Duchenne
Boulogne-sur-Mer, , France
Centre Hospitalier de Briey
Briey, , France
Centre Regional Francois Baclesse
Caen, , France
Hopital Louis Pasteur
Chartres, , France
Hopital Beaujon
Clichy, , France
Louis Mourier Hospital
Colombes, , France
Clinique du Parc
Croix, , France
Hopital Drevon
Dijon, , France
Centre Hospitalier Departemental
La Roche-sur-Yon, , France
Hopital Saint - Louis
La Rochelle, , France
Hopital Robert Boulin
Libourne, , France
Polyclinique Du Bois
Lille, , France
Centre Hospital Universitaire Hop Huriez
Lille, , France
Polyclinique des Quatre Pavillons
Lormont, , France
Hopital Saint Joseph
Marseille, , France
Hopital Notre-Dame de Bon Secours
Metz, , France
Centre Hospitalier Intercommunal Le Raincy - Montfermeil
Montfermeil, , France
Hopital Europeen Georges Pompidou
Paris, , France
Hopital Saint Antoine
Paris, , France
CHU Pitie-Salpetriere
Paris, , France
Hopital Tenon
Paris, , France
Hopital Haut Leveque
Pessac, , France
Polyclinique De Courlancy
Reims, , France
Clinique Specialise du Littoral-Cote d'Opale
Saint-Martin-Boulogne, , France
Clinique Charcot
Sainte-Foy-lès-Lyon, , France
C.H. Senlis
Senlis, , France
Hopital Foch
Suresnes, , France
Countries
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References
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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.
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.
Other Identifiers
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GERCOR-C02-1
Identifier Type: -
Identifier Source: secondary_id
GERCOR-C02-1-MIROX
Identifier Type: -
Identifier Source: secondary_id
EU-20567
Identifier Type: -
Identifier Source: secondary_id
SANOFI-GERCOR-C02-1
Identifier Type: -
Identifier Source: secondary_id
CDR0000453815
Identifier Type: -
Identifier Source: org_study_id
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