Optimal Maintenance Therapy With Bevacizumab After Induction in Metastatic Colorectal Cancer (CRC)

Sponsor
AIO-Studien-gGmbH
Study ID
NCT00973609
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

Investigating the efficacy of maintenance and reinduction treatment or no treatment and watchful waiting in subjects with inoperable or irresectable and non-progressive metastatic colorectal cancer after first line induction treatment for 24 weeks with a fluoropyrimidine-, oxaliplatin- and bevacizumab-based chemotherapy. The maintenance treatment with capecitabine or 5-FU/folinic acid and bevacizumab will be compared with a maintenance treatment with bevacizumab alone or no maintenance treatment. Reinduction treatment will be done in case of progression.

Key Dates

First listed
Sep 9, 2009
Start date
Aug 31, 2009
Status verified
Aug 2015
Primary completion
Dec 31, 2014
Completion
Aug 31, 2015

Study Design

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

Arms

  • Active Comparator: Fluoropyrimidine + Bevacizumab
    Standard therapy
  • Experimental: Bevacizumab monotherapy
  • Experimental: No maintenance treatment

Primary Outcome Measure

Time to failure of maintenance and reinduction treatment strategy measured from randomization [ Time Frame: From randomization until second progression after reinduction treatment ]

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