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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01243372

Enrollment

1142

Registered

2010-11-18

Start date

2009-11-30

Completion date

2018-01-31

Last updated

2020-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

recurrent colon cancer, stage IIIA colon cancer, stage IIIB colon cancer, stage IIIC colon cancer, stage IVA colon cancer, stage IVB colon cancer, recurrent rectal cancer, stage III rectal cancer, stage IV rectal cancer

Brief 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.

Interventions

GENETICmutation analysis

OTHERlaboratory biomarker analysis

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Progression-free survival as measured by RECIST	Up to 36 months

Secondary

Measure	Time frame
overall survival	Up to 36 months
tumor response as measured by RECIST	Up to 36 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026