Combination Chemotherapy as First-Line Therapy in Treating Older Patients With Metastatic Colorectal Cancer That Cannot Be Removed By Surgery

Sponsor
Federation Francophone de Cancerologie Digestive
Study ID
NCT00303771
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
75 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) in different doses or combinations may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating colorectal cancer. PURPOSE: This randomized clinical trial is studying how well fluorouracil works together with leucovorin with or without irinotecan in treating older patients with metastatic colorectal cancer .

Key Dates

Start date
Jun 30, 2003
Status verified
May 2016
Primary completion
Jan 31, 2011
Completion
Jan 31, 2011

Study Design

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

Arms

  • Active Comparator: LV5FU2 classique
    LV5FU2 classique
  • Experimental: LV5FU2 classique + irinotécan
    LV5FU2 classique + irinotécan
  • Active Comparator: LV5FU2 simplifié
    LV5FU2 simplifié
  • Experimental: LV5FU2 simplifié+ irinotécan
    LV5FU2 simplifié + irinotécan

Primary Outcome Measure

Progression Free Survival (survie sans progression) [ Time Frame: 2011 ]

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