Biomarkers in Patients With Head and Neck Cancer
Recruitment status was Not yet recruiting
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.
Head and Neck Cancer
Genetic: DNA analysis
Genetic: gene expression analysis
Genetic: mutation analysis
Other: laboratory biomarker analysis
|Official Title:||Detection of DNA Mutations in Head and Neck Squamous Cell Carcinoma|
- Mutation rates of HRAS and PIK3CA [ Designated as safety issue: No ]
- Response rate [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
|Study Start Date:||December 2011|
|Estimated Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01466257
|Principal Investigator:||Christine H. Chung, MD||Sidney Kimmel Comprehensive Cancer Center|