Status:
COMPLETED
Combination Chemotherapy in Treating Patients With Colorectal Cancer and Resectable Metastases
Lead Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Conditions:
Colorectal Cancer
Metastatic Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating patients with colorectal cancer and resectable metastases...
Detailed Description
OBJECTIVES: 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. * Com...
Eligibility Criteria
Inclusion
- MAIN ELIGIBILITY 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
Exclusion
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
284 Patients enrolled
Trial Details
Trial ID
NCT00268398
Start Date
July 1 2002
Last Update
May 22 2012
Active Locations (32)
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1
Institut Sainte Catherine
Avignon, France, 84000
2
Hopital Duffaut
Avignon, France, 84902
3
C.H.G. Beauvais
Beauvais, France, 60021
4
Hopital Saint Andre
Bordeaux, France, 33075