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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

Correlative (BRAF V600E mutation analysis)

Name: laboratory biomarker analysis

Type: Other

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:
Neoplasm of the large intestine
Genes 120
FLCN SDHC MLH1 PMS2 APC EPCAM SDHC PALLD SRC BUB1 APC GREM1 NTHL1 PMS1 PTEN SDHB MSH6 APC KIT SDHD KRAS BMPR1A FAN1 CTNNB1 MSH3 POLD1 KRAS RNF43 KEAP1 DICER1 DLC1 BMPR1A MSH2 MSH6 PIK3CA CDKN2A FGFR3 BMPR1A MUTYH PIK3CA BMPR1A EP300 FOXE1 ENG SMAD7 AXIN2 CHEK2 MLH1 RPS20 BRCA1 RPS19 PRKAR1A APC GPR35 MLH1 AKT1 POLE SMAD4 KIT TP53 TRIP13 COL14A1 MDM2 SMAD4 POLE BRCA2 AKT1 MSH6 HABP2 NRAS MUTYH BUB1B DOCK8 TGFBR2 STK11 AXIN2 EPCAM BUB3 DCC AXIN2 TCF4 KLLN MSH2 APC TP53 SEC23B PTEN TGFBR2 SEMA4A POLD1 PIK3CA PDGFRA MINPP1 APC SH3KBP1 BMPR1A TP53 BUB1 AAGAB SMAD4 BMPR1A MST1 MLH3 MSH2 PALB2 FLCN SDHA PMS2 SDHB BUB1B MSH2 MLH1 CEP57 MLH3 TP53 PTPRJ PMS1 APC CDKN2A APC