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Clinical Trials/NCT01192750
NCT01192750
Completed
Not Applicable

Retrospective Analysis of ERCC1 Expression in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN) Who Received Cisplatin or Cisplatin and Cetuximab

ECOG-ACRIN Cancer Research Group0 sites79 target enrollmentAugust 5, 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Head and Neck Cancer
Sponsor
ECOG-ACRIN Cancer Research Group
Enrollment
79
Primary Endpoint
Association between ERCC1 expression (low or high) with clinical outcomes
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in tissue samples from patients with recurrent and/or metastatic squamous cell cancer of the head and neck previously treated with cisplatin with or without cetuximab.

Detailed Description

OBJECTIVES: * To investigate the association between ERCC1 expression and clinical outcomes (response rate, progression-free survival, and overall survival) in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck who received cisplatin with versus without cetuximab on clinical trial ECOG-E5397. OUTLINE: Archived tumor tissue samples are analyzed for ERCC1 expression by IHC. ERCC1 levels (low or high) are assessed by an H-score and AQUA, a quantitative IHC analysis. Each patient's ERCC1 level result is then compared with the patient's clinical outcome.

Registry
clinicaltrials.gov
Start Date
August 5, 2010
End Date
October 5, 2010
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
ECOG-ACRIN Cancer Research Group
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Association between ERCC1 expression (low or high) with clinical outcomes

Time Frame: 1 month

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