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

Sponsor

ECOG-ACRIN Cancer Research Group (Other)

Overall Status

Completed

CT.gov ID

NCT00002695

Collaborator

National Cancer Institute (NCI) (NIH)

530

Enrollment

Locations

184.3

Actual Duration (Months)

132.5

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Genetic: DNA stability analysis Genetic: microsatellite instability analysis Genetic: mutation analysis Other: laboratory biomarker analysis

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

530 participants

Official Title:

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

Actual Study Start Date :

Jan 17, 1996

Actual Primary Completion Date :

Oct 18, 2002

Actual Study Completion Date :

May 27, 2011

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21231-2410
2	Ireland Cancer Center	Cleveland	Ohio	United States	44106-5065
3	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
4	CCOP - Green Bay	Green Bay	Wisconsin	United States	54301