Combination Chemotherapy in Treating Patients With Colorectal Cancer and Resectable Metastases

Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
Study ID
NCT00268398
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • oxaliplatin, folinic acid, fluorouracil — DRUG
    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)
  • oxaliplatin, irinotecan, folinic acid, fluorouracil — DRUG
    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)

Study Details

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.

Key Dates

Start date
Jul 31, 2002
Status verified
May 2012
Primary completion
Dec 31, 2011

Study Design

Enrollment
284 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: FOLFOX4
  • Experimental: FOLFOX7 followed by FOLFIRI

Primary Outcome Measure

disease-free survival [ Time Frame: 2-year ]

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