An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer (RELEVANT)
- Conditions
- Colorectal Cancer
- Registration Number
- NCT01697449
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This prospective observational study will evaluate the safety and efficacy of Avastin (bevacizumab) in patients with metastatic colorectal cancer. Data will be collected from patients receiving Avastin in combination with chemotherapy according to registered indication in routine clinical practice.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 191
- Adult patients, >/= 18 years of age
- Metastatic colorectal cancer
- Prescribed to receive Avastin according to registered indication
- Patients not eligible for Avastin treatment according to the Summary of Product Characteristics
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants With At Least One Adverse Event (AE) Up to 65 months An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Clinical Benefit of Complete Response [CR], Partial Response [PR] or Stable Disease [SD] Per Response Evaluation Criteria in Solid Tumors (RECIST) Up to 65 months Per RECIST, CR was defined as the disappearance of all target and non-target lesions and normalization of tumor marker level; PR was defined as at least a 30 percentage (%) decrease in the sum of the longest diameter of target lesions, taking as reference the screening sum longest diameter; SD for target lesions was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started and SD for non-target lesions defined as persistence of 1 or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and nontarget lesions) or the unequivocal progression of existing non-target lesions.
Percentage of Participants Who Were Resectable Postbaseline Among the Participants Who Were Unresectable at Baseline Up to 65 months Percentage of Participants With Disease Progression or Death Up to 65 months Per RECIST, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and nontarget lesions) or the unequivocal progression of existing non-target lesions.
Progression Free Survival (PFS) Up to 65 months PFS was defined as the time from the date of informed consent until the date when the participant had progression of disease or died due to any cause. Participants who left the study for reasons other than progression of the disease were censored at the time of their last tumor assessment. Per RECIST, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of 1 or more new lesions (target and non-target lesions) or the unequivocal progression of existing non-target lesions.