Biomarkers in Tissue Samples From Patients With Recurrent or Metastatic Head and Neck Cancer Treated on ECOG-E1395 and ECOG-E3301
This study is not yet open for participant recruitment.
Verified December 2011 by National Cancer Institute (NCI)
Sponsor:
Eastern Cooperative Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01487733
First received: December 6, 2011
Last updated: NA
Last verified: December 2011
History: No changes posted
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Purpose
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment.
PURPOSE: This research study is studying biomarkers in tissue samples from patients with recurrent or metastatic head and neck cancer treated on ECOG-E1395 and ECOG-E3301.
| Condition | Intervention |
|---|---|
|
Head and Neck Cancer |
Genetic: gene expression analysis Genetic: in situ hybridization Other: immunohistochemistry staining method Other: laboratory biomarker analysis |
| Study Type: | Observational |
| Official Title: | Analysis of HPV and Other Biomarkers in Specimens From ECOG Studies in Recurrent or Metastatic Head and Neck Cancer (E1395 and E3301) |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Treatment response [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Survival endpoints (e.g., overall survival and progression-free survival) [ Designated as safety issue: No ]
| Estimated Enrollment: | 155 |
| Study Start Date: | January 2012 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- To investigate the association between biomarkers (HPV tumor status and ERCC1 expression) and clinical outcomes in a population of patients with recurrent or metastatic head and neck cancer.
- To develop the ability to select patients likely to respond to therapy and to avoid treatment with ineffective therapies, especially since these therapies have substantial toxicity.
- To estimate response and survival rates of HPV-negative and -positive patients in each study. (exploratory)
OUTLINE: Tumor HPV status is determined by in situ hybridization (ISH) and all samples also undergo immunostaining for p16. ERCC1 expression is evaluated with AQUA, a quantitative IHC analysis.
Samples are classified into two categories based on their biomarker status: HPV tumor status (negative versus positive), and ERCC1 expression level (low versus high).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Tissue specimens from patients with recurrent or metastatic head and neck cancer treated on ECOG-E1395 and ECOG-E3301
- Stage III, IV, or recurrent disease
- Squamous cell disease
Any of the following diagnoses:
- Lip and oral cavity
- Oropharynx
- Hypopharynx
- Larynx
- Paranasal sinus and nasal cavity
- Squamous neck cancer
- Salivary gland
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Robert L. Comis, ECOG Group Chair's Office |
| ClinicalTrials.gov Identifier: | NCT01487733 History of Changes |
| Other Study ID Numbers: | CDR0000717143, ECOG-E4L10T1 |
| Study First Received: | December 6, 2011 |
| Last Updated: | December 6, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
metastatic squamous neck cancer with occult primary squamous cell carcinoma metastatic squamous neck cancer with occult primary 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 nasopharynx recurrent squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity salivary gland squamous cell carcinoma 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 nasopharynx stage III squamous cell carcinoma of the oropharynx |
stage III squamous cell carcinoma of the paranasal sinus and nasal cavity 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 recurrent salivary gland cancer |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Neoplasms by Site Neoplasms |
ClinicalTrials.gov processed this record on June 17, 2013