Biomarkers in Patients With Head and Neck Cancer | NCT01466257 | Trialant
NCT01466257
Sponsor
ECOG-ACRIN Cancer Research Group
Status
Completed
Last Update Posted
May 19, 2017Actual
Enrollment
70Actual
Phase
Not provided
Conditions
Head and Neck Cancer
Interventions
cetuximab
cisplatin
DNA analysis
gene expression analysis
mutation analysis
laboratory biomarker analysis
Countries
Not provided
Protocol Section
Identification Module
NCT ID
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT01466257
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CDR0000715520
Secondary IDs
ID
Type
Description
Link
ECOG-E5397T2
Brief Title
Biomarkers in Patients With Head and Neck Cancer
Official Title
Detection of DNA Mutations in Head and Neck Squamous Cell Carcinoma
Acronym
Not provided
Organization
Eastern Cooperative Oncology GroupNETWORK
Status Module
Record Verification Date
May 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Nov 21, 2011Actual
Primary Completion Date
Jan 1, 2012Actual
Completion Date
Jan 1, 2012Actual
First Submitted Date
Nov 2, 2011
First Submission Date that Met QC Criteria
Nov 2, 2011
First Posted Date
Nov 7, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
May 17, 2017
Last Update Posted Date
May 19, 2017Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
ECOG-ACRIN Cancer Research GroupNETWORK
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
No data available
No data is available for this block.
Description Module
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.
Conditions Module
Conditions
Head and Neck Cancer
Keywords
metastatic squamous neck cancer with occult primary squamous cell carcinoma
recurrent metastatic squamous neck cancer with occult primary
recurrent squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the larynx
recurrent squamous cell carcinoma of the lip and oral cavity
recurrent squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
stage III squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the larynx
stage III squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
Design Module
Study Type
Observational
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not provided
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
70Actual
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
cetuximab
Biological
cisplatin
Drug
DNA analysis
Genetic
gene expression analysis
Genetic
mutation analysis
Genetic
laboratory biomarker analysis
Other
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Mutation rates of HRAS and PIK3CA
1 day
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
DISEASE CHARACTERISTICS:
Treated on protocol ECOG-E5397
PATIENT CHARACTERISTICS:
Not specified
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
120 Years
Standard Ages
AdultOlder Adult
Study Population
Samples submitted for research from patients participating in E5397
Sampling Method
Non-Probability Sample
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Christine H. Chung, MD
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Principal Investigator
Locations
Not provided
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D006258
Head and Neck Neoplasms
D000077195
Squamous Cell Carcinoma of Head and Neck
Ancestor Terms
ID
Term
D009371
Neoplasms by Site
D009369
Neoplasms
D002294
Carcinoma, Squamous Cell
D002277
Carcinoma
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
MeSH Terms
ID
Term
D000068818
Cetuximab
D002945
Cisplatin
D020869
Gene Expression Profiling
Ancestor Terms
ID
Term
D061067
Antibodies, Monoclonal, Humanized
D000911
Antibodies, Monoclonal
D000906
Antibodies
D007136
Immunoglobulins
Browse Leaves
Not provided
Browse Branches
Not provided
stage IV squamous cell carcinoma of the hypopharynx
stage IVA squamous cell carcinoma of the larynx
stage IVA squamous cell carcinoma of the lip and oral cavity
stage IVA squamous cell carcinoma of the oropharynx
stage IVA squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IVB squamous cell carcinoma of the larynx
stage IVB squamous cell carcinoma of the lip and oral cavity
stage IVB squamous cell carcinoma of the oropharynx
stage IVB squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IVC squamous cell carcinoma of the larynx
stage IVC squamous cell carcinoma of the lip and oral cavity
stage IVC squamous cell carcinoma of the oropharynx
stage IVC squamous cell carcinoma of the paranasal sinus and nasal cavity
untreated metastatic squamous neck cancer with occult primary