Evaluating BRAF Mutations as Predictors of Efficacy in Cetuximab-Treated Colorectal Cancer Patients: A Retrospective Study of Tissues From CALGB / SWOG

Status: Completed
Intervention Type: Genetic, Other
Study Type: Observational

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.

Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No


• Participation in CALGB-C80405

• Have KRAS WT or KRAS mut tumor

• Randomized to treatment with either bevacizumab or cetuximab alone

• Patients randomized to the combination therapy are not eligible

• Available specimens at the PCO for BRAF mutation detection

• Patient consent for use of samples

Time Frame
Start Date: November 2009
Completion Date: January 2018
Target number of participants: 1142
Correlative (BRAF V600E mutation analysis)
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.
Related Therapeutic Areas
Leads: Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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