An Observational Study of Avastin in Participants With Metastatic Colorectal Cancer (KORALLE)
- Registration Number
- NCT01775644
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This observational multicenter study will evaluate the differences in progression-free survival defined in specific subgroups of participants with metastatic colorectal cancer receiving bevacizumab (Avastin). Further, safety and efficacy in daily routine will be assessed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3003
Inclusion Criteria
- Participants with metastatic colorectal cancer where physician has decided to give a first-line, fluoro-pyrimidine-based combination therapy with bevacizumab according to Summary of Product Characteristics (SmPC)
Read More
Exclusion Criteria
- Contraindications for bevacizumab according to SmPC
Read More
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Metastatic Colorectal Cancer Participants Bevacizumab Administration of treatment will be as used in normal daily routine under local labelling in 4 subgroups- participants with liver and/or lung metastases, potentially resectable after a response to a systemic therapy and clinically operable; participants with tumor related symptoms, risks for complications or fast progression for whom quick proliferation control is needed; "asymptomatic" participants (indolent tumor) without the option of a metastases resection (no pressure for remission) for whom the aim of the therapy is proliferation control and participants without classification.
- Primary Outcome Measures
Name Time Method Median Progression-Free Survival Time in Defined Participant Subgroups as Assessed by Response Evaluation Criteria In Solid Tumors (RECIST) Baseline up to 5 years
- Secondary Outcome Measures
Name Time Method Percentage of Participants by Carcinoembryonic Antigen Tumor Marker Baseline Percentage of Participants by Cancer Antigen 19-9 Tumor Marker Baseline Percentage of Participants by Comorbidity Index as per Carlson Method Baseline Percentage of Participants by Prognostic Factors Baseline up to 5 years Percentage of Participants by Eastern Cooperative Oncology Group (ECOG) Performance Status Baseline Percentage of Participants by RAS Mutation Status Baseline Percentage of Participants by Cancer Metastasation Status Baseline Percentage of Participants According to Previous Treatment Regimen of Bevacizumab Baseline Progression-Free Survival as Assessed by RECIST (Overall) Baseline up to 5 years Overall Survival in Daily Routine Practice Baseline up to 5 years Overall Survival in Defined Participant Subgroups in Daily Routine Practice Baseline up to 5 years Percentage of Participants Showing Overall Response in Daily Routine Practice as Assessed by RECIST Baseline up to 5 years Number of Treatment Application Schemes of Bevacizumab Daily Routine Practice Baseline up to 5 years Number of Participants With Adverse Event Baseline up to 5 years Number of Participants With Reason for Bevacizumab Treatment Modifications and Discontinuation in Defined Participant Subgroups Baseline up to 5 years Total Cumulative Therapy Dose of Bevacizumab Baseline up to 5 years Percentage of Participants With Treatment Success Baseline up to 5 years Percentage of Participants With Resection Baseline up to 5 years Number of Physicians Satisfied With Treatment Baseline up to 5 years Percentage of Participants Without Resection by Reason Baseline up to 5 years Percentage of Participants With Follow-Up therapy Baseline up to 5 years Percentage of Participants in Defined Participant Subgroups Showing Overall Response in Daily Routine Practice as Assessed by RECIST Baseline up to 5 years