N/A
Completed N=201
Observational Study of Bevacizumab [Avastin] in Patients With Metastatic Colorectal Cancer (AVASTART)
Source: ClinicalTrials.gov NCT01089413 ↗Enrolled (actual)
201
Serious AEs
46.8%
Results posted
Dec 2015
Primary outcomePrimary: Duration of Bevacizumab Treatment — 6.50; 5.09; 5.95 months — p=0.8579
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Bevacizumab Treatment |
6.50; 5.09; 5.95 | 0.8579 |
| SECONDARY Progression-Free Survival (PFS) |
11.47; 12.68; 11.53 | 0.1555 |
| SECONDARY Percentage of Participants With Best Overall Response |
3.7; 3.4; 7.7; 3.9; 43.9; 46.6 | — |
| SECONDARY Percentage of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status |
47.2; 41.3; 22.2; 43.9; 44.4; 46.0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01089413). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.