Eligibility

Ages Eligible for Study

Up to 75 years

Genders Eligible for Study

Both

Keywords

Colorectal cancer, metastatic, chemotherapy, and randomized trial

Sponsors

Other

Institut Gustave Roussy

Other

Fondation Francaise de Cancerologie Digestive

Industry

Sanofi-Aventis

Inclusion Criteria

- Histologically confirmed metastatic colorectal adenocarcinoma

- Unresectable metastasis

- 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

Exclusion Criteria

- 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

Detailed Description

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.