Analysis of Tumor Tissue and Lymph Nodes Surgically Removed From Patients With Cancers of the Head and Neck

Study Overview
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Brief Summary
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RATIONALE: Diagnostic procedures, such as analysis of tumor tissue and lymph nodes that have been surgically removed, may improve the treatment of patients with cancers of the head and neck. PURPOSE: Diagnostic trial to determine if analyzing tumor tissue and lymph nodes surgically removed from patients with cancers of the head and neck can predict recurrence of the cancer.

Detailed Description
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OBJECTIVES: Determine whether molecular detection of p53 mutation in cancerous cells of histologically negative tumor margins can predict local recurrence in patients with squamous cell carcinoma of the upper aerodigestive tract. Determine the incidence of p53 mutation in this population and its correlation with clinical parameters. Determine whether molecular detection of cancerous cells in lymph nodes from stage N0-1 neck dissections can predict survival and the risks of regional recurrence and distant metastases in these patients. OUTLINE: This is a multicenter study. Patients undergo standard curative resection and neck node dissection (if appropriate). Specimens are collected from tumor tissue (necrosis-free, if possible), each wound quadrant, any neck disease with clinically negative nodes, and any neck disease with a single positive node for histologic and molecular analysis. Tissue and cells are examined for p53 mutation and DNA microsatellite repeat alterations. Patients undergo adjuvant radiotherapy and/or chemotherapy, as appropriate for clinical staging and histopathology, at the discretion of the participating clinician. Patients do not receive results of genetic testing and the results do not affect treatment. Patients are followed every 6 months for 3 years and then annually thereafter. PROJECTED ACCRUAL: A total 530 patients will be accrued for this study within 3.5 years.

Official Title
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CLINICAL EFFICACY OF MOLECULAR ANALYSIS OF SURGICAL MARGINS AND REGIONAL LYMPH NODES IN MANAGEMENT OF HEAD AND NECK SQUAMOUS CELL CARCINOMA

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Genetic: DNA stability analysis
* Genetic: microsatellite instability analysis
* Genetic: mutation analysis
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of squamous cell carcinoma of the upper aerodigestive tract (excluding the nasopharynx) for which curative resection is scheduled Recurrent disease allowed if resectable Patients with clinically and histologically proven stage N0-1 neck disease who are undergoing dissection are eligible for analysis of occult nodal disease No distant metastasis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other malignancy within the past 5 years except nonmelanomatous skin cancer or lymphoma PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior limited chemotherapy to the index lesion allowed Endocrine therapy: Not specified Radiotherapy: Prior limited radiotherapy to the index lesion allowed Surgery: See Disease Characteristics Prior limited surgery to the index lesion allowed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: DNA stability analysis|nan|
|Genetic: microsatellite instability analysis|nan|
|Genetic: mutation analysis|nan|
|Other: laboratory biomarker analysis|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the lip and oral cavity, stage III squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, stage I squamous cell carcinoma of the oropharynx, stage II squamous cell carcinoma of the oropharynx, stage III squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, stage I squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx, stage I squamous cell carcinoma of the larynx, stage II squamous cell carcinoma of the larynx, stage III squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, stage I squamous cell carcinoma of the paranasal sinus and nasal cavity, stage II squamous cell carcinoma of the paranasal sinus and nasal cavity, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity