Combination Chemotherapy in Treating Patients With Colorectal Cancer and Resectable Metastases (MIROX)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00268398|
Recruitment Status : Completed
First Posted : December 22, 2005
Last Update Posted : May 22, 2012
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Metastatic Cancer Chemotherapy||Drug: oxaliplatin, folinic acid, fluorouracil Drug: oxaliplatin, irinotecan, folinic acid, fluorouracil||Phase 3|
- Compare the 2-year disease-free survival rate in patients treated with these regimens.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||284 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||July 2002|
|Primary Completion Date :||December 2011|
|Active Comparator: FOLFOX4||
Drug: 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)
|Experimental: FOLFOX7 followed by FOLFIRI||
Drug: 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)
- disease-free survival [ Time Frame: 2-year ]
- Overall survival [ Time Frame: 2-year, 3-year, 5-year ]
- Tolerability [ Time Frame: 2-year ]
- Quality of life [ Time Frame: 2-year ]
- Pharmacogenetics [ Time Frame: 2-year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00268398
|Institut Sainte Catherine|
|Avignon, France, 84000|
|Avignon, France, 84902|
|Beauvais, France, 60021|
|Hopital Saint Andre|
|Bordeaux, France, 33075|
|Centre Hospitalier Docteur Duchenne|
|Boulogne Sur Mer, France, 62200|
|Hopital Ambroise Pare|
|Boulogne-Billancourt, France, F-92104|
|Centre Hospitalier de Briey|
|Briey, France, 54151|
|Centre Regional Francois Baclesse|
|Caen, France, 14076|
|Hopital Louis Pasteur|
|Chartres, France, 28018|
|Clichy, France, 92118|
|Louis Mourier Hospital|
|Colombes Cedex, France, 92701|
|Clinique du Parc|
|Croix, France, 59170|
|Dijon, France, 21000|
|Centre Hospitalier Departemental|
|La Roche Sur Yon, France, F-85025|
|Hopital Saint - Louis|
|La Rochelle, France, 17000|
|Hopital Robert Boulin|
|Libourne, France, 33500|
|Polyclinique Du Bois|
|Lille, France, 59000|
|Centre Hospital Universitaire Hop Huriez|
|Lille, France, 59037|
|Polyclinique des Quatre Pavillons|
|Lormont, France, 33310|
|Hopital Saint Joseph|
|Marseille, France, 13008|
|Hopital Notre-Dame de Bon Secours|
|Metz, France, 57038|
|Centre Hospitalier Intercommunal Le Raincy - Montfermeil|
|Montfermeil, France, 93370|
|Hopital Europeen Georges Pompidou|
|Paris, France, 75015|
|Hopital Saint Antoine|
|Paris, France, 75571|
|Paris, France, 75651|
|Paris, France, 75970|
|Hopital Haut Leveque|
|Pessac, France, 33604|
|Polyclinique De Courlancy|
|Reims, France, F-51100|
|Clinique Specialise du Littoral-Cote d'Opale|
|Saint Martin Boulogne, France, 62280|
|Sainte Foy Les Lyon, France, 69110|
|Senlis, France, 60309|
|Suresnes, France, 92151|
|Study Chair:||Mohamed Hebbar, MD||Centre Hospital Universitaire Hop Huriez|