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.

Condition	Treatment or Intervention
Lip Neoplasms Mouth Neoplasms Oropharyngeal Cancer Head and Neck Cancer	Procedure: diagnostic  Procedure: genetics

Further Study Details: 

OBJECTIVES: I. 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. II. Determine the incidence of p53 mutation in this population and its correlation with clinical parameters. III. 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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--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

--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

--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

Maryland
      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231-2410,  United States
Ohio
      Ireland Cancer Center, Cleveland,  Ohio,  44106-5065,  United States
Pennsylvania
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States
Wisconsin
      CCOP - Green Bay, Green Bay,  Wisconsin,  54301,  United States

Study chairs or principal investigators

Wayne M. Koch,  Study Chair,  Eastern Cooperative Oncology Group   

Study ID Numbers:  CDR0000064467; E-4393
Record last reviewed:  April 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002695
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08