A Multicenter, Non-interventional, Post-authorization Study to Observe in Daily Clinical Practice the Treatment Duration of Patients Treated With Avastin (Bevacizumab) in 1st Line mCRC in Belgium
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 201
- Primary Endpoint
- Duration of Bevacizumab Treatment
Study Overview
Brief Summary
This observational study will assess the treatment duration, progression-free survival, reason for stopping treatment and patient and tumor characteristics of bevacizumab [Avastin] treatment in patients with metastatic colorectal cancer. Data will be collected for approximately 34 months. The target sample size is >300 patients.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •adult patients =/<18 years of age
- •metastatic colorectal cancer
- •patients for whom the physician has prescribed bevacizumab [Avastin] for the treatment of 1st line metastatic colorectal cancer
- •patients, who have given written informed consent
Exclusion Criteria
- •hypersensitivity to recombinant human or humanised antibodies
- •pregnancy or breast-feeding
Arms & Interventions
Cohort
Intervention: bevacizumab [Avastin] (Drug)
Outcomes
Primary Outcomes
Duration of Bevacizumab Treatment
Time Frame: Baseline up to end of treatment (up to approximately 3 years)
Duration of bevacizumab treatment (in months) was defined as: (last treatment date - first treatment date plus \[+\] 1)/30.44. Duration of treatment was estimated using Kaplan-Meier method. Results are reported as per age groups (\<70 years and greater than or equal to \[≥\] 70 years) as well as for overall participants.
Secondary Outcomes
- Progression-Free Survival (PFS)(Baseline up to disease progression or death (up to approximately 3 years))
- Percentage of Participants With Best Overall Response(Baseline up to disease progression or death (up to approximately 3 years))
- Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status(Baseline up to Cycle 51 (1 cycle = 21 days))