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


N/A
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

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


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.

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

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Progression-free survival as measured by RECIST

Safety Issue:

No

Principal Investigator

Najjia N. Mahmoud, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

Unspecified

Study ID:

CDR0000688745

NCT ID:

NCT01243372

Start Date:

November 2009

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • 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
  • Colorectal Neoplasms

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