NCT01466257

Biomarkers in Patients With Head and Neck Cancer

Detection of DNA Mutations in Head and Neck Squamous Cell Carcinoma

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 70 (actual)
• Sponsor: ECOG-ACRIN Cancer Research Group · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
BIOLOGICAL	cetuximab
DRUG	cisplatin
GENETIC	DNA analysis
GENETIC	gene expression analysis
GENETIC	mutation analysis
OTHER	laboratory biomarker analysis

Timeline

• Start date: 2011-11-21
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2011-11-07
• Last updated: 2017-05-19