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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


N/A
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

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


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.

Inclusion 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

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

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Wayne M. Koch, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000064467

NCT ID:

NCT00002695

Start Date:

January 1996

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • 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
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

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