Trials / Completed
CompletedNCT01243372
Biomarkers in Predicting Response to Cetuximab in Patients With Advanced Colorectal Cancer
Evaluating BRAF Mutations as Predictors of Efficacy in Cetuximab-Treated Colorectal Cancer Patients: A Retrospective Study of Tissues From CALGB / SWOG
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,142 (estimated)
- Sponsor
- Alliance for Clinical Trials in Oncology · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Studying samples of tissue in the laboratory from patients who received cetuximab may help doctors understand and predict how well patients will respond to treatment. PURPOSE: This research study is studying biomarkers in predicting response to cetuximab in patients with advanced colorectal cancer.
Detailed description
OBJECTIVES: Primary * To determine, among patients with advanced CRC, whether the effect of treatment (cetuximab vs bevacizumab) on progression-free survival (PFS) depends on tumor BRAF V600E mutational status. Secondary * To study the relationships between tumor BRAF V600E mutational status, OS, and tumor response. OUTLINE: This is a multicenter study. Previously collected formalin-fixed and paraffin-embedded baseline tumor samples are analyzed for BRAF V600E mutation. Mutation status is correlated with clinical response and outcome data from patients enrolled on CALGB-C80405.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | mutation analysis | |
| OTHER | laboratory biomarker analysis |
Timeline
- Start date
- 2009-11-01
- Primary completion
- 2018-01-01
- Completion
- 2018-01-01
- First posted
- 2010-11-18
- Last updated
- 2020-07-24
Source: ClinicalTrials.gov record NCT01243372. Inclusion in this directory is not an endorsement.