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Home > "A" Clinical Trials Conditions > Analysis of Tumor Tissue and Lymph Nodes Surgically Removed From Patients With Cancers of the Head and Neck  Analysis of Tumor Tissue and Lymph Nodes Surgically Removed From Patients With Cancers of the Head and Neck
Analysis of Tumor Tissue and Lymph Nodes Surgically Removed From Patients With Cancers of the Head and Neck
For Condition: Lip Neoplasms,Mouth Neoplasms,Oropharyngeal Cancer,Head and Neck Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Eastern Cooperative Oncology Group
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Diagnostic
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WayneKoch, Study Chair, Eastern Cooperative Oncology Group
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
CCOP - Green Bay
Green Bay, Wisconsin, 54301
United States
Additional Information:
Study ID Numbers: CDR0000064467; E-4393
Study Start Date: January 1996
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002695
Other Mouth Neoplasms Studies:
1. Analysis of Tumor Tissue and Lymph Nodes Surgically Removed From Patients With Cancers of the Head and Neck
2. Safety & Efficacy Study of Benzydamine Oral Rinse for the treatment of oral mucositis (mouth sores) resulting from radiation therapy for cancer of the oral cavity, oropharynx, or nasopharynx
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Analysis of Tumor Tissue and Lymph Nodes Surgically Removed From Patients With Cancers of the Head and Neck
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