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Biomarkers in Patients With Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01466257
Recruitment Status : Completed
First Posted : November 7, 2011
Last Update Posted : May 19, 2017
Information provided by (Responsible Party):

November 2, 2011
November 7, 2011
May 19, 2017
November 21, 2011
January 1, 2012   (Final data collection date for primary outcome measure)
Mutation rates of HRAS and PIK3CA [ Time Frame: 1 day ]
Mutation rates of HRAS and PIK3CA
Complete list of historical versions of study NCT01466257 on ClinicalTrials.gov Archive Site
Not Provided
  • Response rate
  • Progression-free survival
  • Overall survival
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Biomarkers in Patients With Head and Neck Cancer
Detection of DNA Mutations in Head and Neck Squamous Cell Carcinoma

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.


  • 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.

Observational Model: Other
Time Perspective: Retrospective
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Non-Probability Sample
Samples submitted for research from patients participating in E5397
Head and Neck Cancer
  • Biological: cetuximab
  • Drug: cisplatin
  • Genetic: DNA analysis
  • Genetic: gene expression analysis
  • Genetic: mutation analysis
  • Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
January 1, 2012
January 1, 2012   (Final data collection date for primary outcome measure)


  • Treated on protocol ECOG-E5397


  • Not specified


  • See Disease Characteristics
Sexes Eligible for Study: All
18 Years to 120 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Principal Investigator: Christine H. Chung, MD Sidney Kimmel Comprehensive Cancer Center
Eastern Cooperative Oncology Group
May 2017