Status:
COMPLETED
Trial Comparing Two Strategies of Chemotherapy for Metastatic Colorectal Cancer
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Collaborating Sponsors:
Fondation Francaise de Cancerologie Digestive
Sanofi
Conditions:
Colorectal Cancer
Metastasis
Eligibility:
All Genders
Up to 75 years
Phase:
PHASE3
Brief Summary
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....
Detailed Description
Background: The addition of oxaliplatin and irinotecan to 5-FU improves tumor response rate and progression-free survival in patients with advanced colorectal cancer compared with 5-FU alone, but inc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2006
Estimated Enrollment :
570 Patients enrolled
Trial Details
Trial ID
NCT00126256
Start Date
February 1 2002
End Date
February 1 2006
Last Update
August 13 2015
Active Locations (1)
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1
Institut Gustave-Roussy
Villejuif, France, 94805