Trial Comparing Two Strategies of Chemotherapy for Metastatic Colorectal Cancer
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The standard treatment of metastatic colorectal cancer is based on systemic chemotherapy. Several effective drugs are currently available and can be administered either sequentially or in combination. Most patients receive 2 or 3 lines of chemotherapy. The aim of this randomized trial is to evaluate the potential benefit of a bitherapy with 5-fluorouracil (5-FU) and oxaliplatin as first line chemotherapy compared with a sequential chemotherapy with 5-FU alone as first line chemotherapy followed by the combination of 5-FU with oxaliplatin in case of progressive disease, in terms of progression-free survival and overall survival in patients with advanced colorectal cancer.
Progression-free survival after two lines of chemotherapy, defined as the time duration from randomization until progression after two lines of chemotherapy or death whatever the cause in the absence of progression or last-follow-up
Secondary Outcome Measures :
Progression-free survival after the first and the third line of chemotherapy
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Bidimensionally measurable disease (World Health Organization [WHO] criteria)
WHO performance status of 2 or less
Adequate hematologic functions (neutrophil count, at least 1500 per cubic millimeter; and platelet count, at least 100,000 per cubic millimetre)
Adequate renal function (serum creatinine, less than 125 micromol per liter)
Adequate liver function (bilirubin, not more than 5 times the upper limit of normal)
No previous chemotherapy other than previous adjuvant chemotherapy or concomitant chemoradiotherapy with 5-fluorouracil and leucovorin for the treatment of the primary tumor completed at least 6 months before inclusion
Signed written inform consent
Quality of life questionnaire (QLQ C-30) filled out
Pregnant or breast - feeding women
Impossibility of regular follow-up for psychological, social or geographical reason
Severe cardiac, respiratory, renal or hepatic failure
Active coronary heart disease
Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study
Central nervous system metastases
Past history of second malignancies
Another investigational drug
Chronic inflammatory bowel disease
Previous chemotherapy with irinotecan or oxaliplatin based regimens