This trial is active, not recruiting.

Condition head and neck cancer
Treatments dna stability analysis, microsatellite instability analysis, mutation analysis, laboratory biomarker analysis
Sponsor Eastern Cooperative Oncology Group
Collaborator National Cancer Institute (NCI)
Start date January 1996
Trial size 530 participants
Trial identifier NCT00002695, CDR0000064467, E-4393


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.

United States No locations recruiting
Other Countries No locations recruiting

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).