Biomarkers in Patients With Head and Neck Cancer
|ClinicalTrials.gov Identifier: NCT01466257|
Recruitment Status : Completed
First Posted : November 7, 2011
Last Update Posted : May 19, 2017
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.
|Condition or disease||Intervention/treatment|
|Head and Neck Cancer||Biological: cetuximab Drug: cisplatin Genetic: DNA analysis Genetic: gene expression analysis Genetic: mutation analysis Other: laboratory biomarker analysis|
- 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 Type :||Observational|
|Actual Enrollment :||70 participants|
|Official Title:||Detection of DNA Mutations in Head and Neck Squamous Cell Carcinoma|
|Actual Study Start Date :||November 21, 2011|
|Primary Completion Date :||January 1, 2012|
|Study Completion Date :||January 1, 2012|
- Mutation rates of HRAS and PIK3CA [ Time Frame: 1 day ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01466257
|Principal Investigator:||Christine H. Chung, MD||Sidney Kimmel Comprehensive Cancer Center|