Biomarkers in Patients With Head and Neck Cancer

Completed

• Conditions: Head and Neck Cancer

• Registration Number: NCT01466257
• Lead Sponsor: ECOG-ACRIN Cancer Research Group

Brief Summary

RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment.

PURPOSE: This research study is studying biomarkers in patients with head and neck cancer.

Detailed Description

OBJECTIVES:

* To determine the mutation rates of HRAS and PIK3CA in patients with head and neck squamous cell carcinoma (HNSCC) who were treated with cisplatin/placebo and cisplatin/cetuximab on protocol ECOG-E5397.

* To determine the association between HRAS or PIK3CA mutation status and clinical benefits (i.e., response, progression-free survival, and overall survival) in patients treated with cisplatin/cetuximab compared with those receiving cisplatin/placebo on protocol ECOG-E5397.

OUTLINE: DNA is isolated from one unstained slide per patient. The mutations in HRAS and PIK3CA are determined using BEAMING technology.

Study Timeline

• Study First Submitted: 2011-11-02
• Study First Submitted QC: 2011-11-02
• Study First Posted: 2011-11-06
• Study Start: 2011-11-21
• Primary Completion: 2012-01-01
• Study Completion: 2012-01-01
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-17
• Last Update Posted: 2017-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mutation rates of HRAS and PIK3CA	1 day