An Observational Study of First-Line Bevacizumab (Avastin) With Fluoropyrimidine-Based Chemotherapy in Participants With Metastatic Colorectal Cancer
- Sponsor
- Hoffmann-La Roche
- Study ID
- NCT01712347
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Bevacizumab — DRUGBevacizumab will be administered as per approved label.
- Chemotherapy — DRUGThe protocol does not specify the chemotherapy regimen to be used, the choice of chemotherapy will be at the discretion of treating physician.
Study Details
This multicenter observational study will evaluate the efficacy and safety of first-line bevacizumab (Avastin) in combination with fluoropyrimidine-based chemotherapy in participants with metastatic colorectal cancer (mCRC). Participants for whom the treating physician has decided to initiate first-line fluoropyrimidine based chemotherapy in combination with bevacizumab will be observed for approximately 4 years.
Key Dates
- First listed
- Oct 23, 2012
- Start date
- Oct 11, 2012
- Status verified
- Jun 2017
- Primary completion
- Jul 1, 2016
- Completion
- Jul 1, 2016
Study Design
- Enrollment
- 351 participants (actual)
Arms
- Arm: mCRC ParticipantsmCRC participant will receive bevacizumab as per approved label with the approved first-line fluoropyrimidine based chemotherapy, as per physician discretion. The protocol does not specify the chemotherapy regimen to be used, the choice of chemotherapy will be at the discretion of treating physician.
Primary Outcome Measure
Overall survival from the time of starting first-line therapy [ Time Frame: Start of first line therapy until death (up to approximately 4 years) ]
Related Studies
- Evaluation for NCI Surgery Branch Clinical Research ProtocolsRecruiting · National Cancer Institute (NCI) · Bethesda, Maryland
- Gastrointestinal Biomarkers in Tissue and Biological Fluid Samples From Colorectal Cancer PatientsRecruiting · Vanderbilt University Medical Center · Nashville, Tennessee
- ColoCare Study - Colorectal Cancer CohortRecruiting · University of Utah · Los Angeles, California
- Feasibility of the LUM Imaging System for Detection of Gastrointestinal CancersPHASE1/PHASE2 · Recruiting · Lumicell, Inc. · Boston, Massachusetts