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Report for Clinical Trial NCT01243372

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT01243372 Colorectal Cancer
MeSH:Colorectal Neoplasms
HPO:Neoplasm of the large intestine

2 Interventions

Name: mutation analysis

Type: Genetic
Group Labels: 1

Correlative (BRAF V600E mutation analysis)

Name: laboratory biomarker analysis

Type: Other
Group Labels: 1

Correlative (BRAF V600E mutation analysis)


Primary Outcomes

Measure: Progression-free survival as measured by RECIST

Time: Up to 36 months

Secondary Outcomes

Measure: overall survival

Time: Up to 36 months

Measure: tumor response as measured by RECIST

Time: Up to 36 months

Time Perspective: Retrospective

Case-Only


There is one SNP

SNPs


1 V600E

DISEASE CHARACTERISTICS: - 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 DISEASE CHARACTERISTICS: - 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 Colorectal Cancer Colorectal Neoplasms 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. --- V600E ---

Secondary - To study the relationships between tumor BRAF V600E mutational status, OS, and tumor response. --- V600E ---

Previously collected formalin-fixed and paraffin-embedded baseline tumor samples are analyzed for BRAF V600E mutation. --- V600E ---



HPO Nodes


HPO: