Trial Comparing Two Strategies of Chemotherapy for Metastatic Colorectal Cancer

Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Study ID
NCT00126256
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 5-fluorouracil — DRUG
  • leucovorin — DRUG
  • irinotecan — DRUG
  • oxaliplatin — DRUG

Study Details

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.

Key Dates

Start date
Feb 28, 2002
Status verified
Aug 2015
Primary completion
Feb 28, 2006
Completion
Feb 28, 2006

Study Design

Enrollment
570 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Primary Outcome Measure

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

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