Combination Chemotherapy and Bevacizumab With or Without Bevacizumab Maintenance Therapy in Treating Patients With Metastatic Colorectal Cancer

Sponsor
Federation Francophone de Cancerologie Digestive
Study ID
NCT00952029
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

RATIONALE: Drugs used in chemotherapy, such as irinotecan hydrochloride, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bevacizumab may stop the growth of colorectal cancer by blocking blood flow to the tumor. It is not yet known whether giving more than one drug (combination chemotherapy) is more effective when given with or without bevacizumab in treating patients with metastatic colorectal cancer. PURPOSE: This randomized phase III trial is studying giving combination chemotherapy with or without bevacizumab to see how well it works in treating patients with metastatic colorectal cancer.

Key Dates

Start date
Mar 31, 2010
Status verified
Mar 2020
Primary completion
Dec 31, 2015
Completion
Jan 31, 2018

Study Design

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

Arms

  • Experimental: Maintenance with bevacizumab
    FOLFIRI + Avastin and during the chemotherapy-free interval maintenance with bevacizumab
  • Active Comparator: No maintenance with bevacizumab
    FOLFIRI + Avastin and during the chemotherapy-free interval NO maintenance

Primary Outcome Measure

Disease-control duration [ Time Frame: one year after last patient included ]

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