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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002695
First Posted: April 11, 2003
Last Update Posted: May 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
  Purpose

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 Intervention
Head and Neck Cancer Genetic: DNA stability analysis Genetic: microsatellite instability analysis Genetic: mutation analysis Other: laboratory biomarker analysis

Study Type: Observational
Official Title: CLINICAL EFFICACY OF MOLECULAR ANALYSIS OF SURGICAL MARGINS AND REGIONAL LYMPH NODES IN MANAGEMENT OF HEAD AND NECK SQUAMOUS CELL CARCINOMA

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ):

Estimated Enrollment: 530
Actual Study Start Date: January 17, 1996
Study Completion Date: May 27, 2011
Primary Completion Date: October 18, 2002 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002695


Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Wisconsin
CCOP - Green Bay
Green Bay, Wisconsin, United States, 54301
Sponsors and Collaborators
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Investigators
Study Chair: Wayne M. Koch, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Publications:
Responsible Party: ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier: NCT00002695     History of Changes
Other Study ID Numbers: CDR0000064467
E-4393
First Submitted: November 1, 1999
First Posted: April 11, 2003
Last Update Posted: May 19, 2017
Last Verified: May 2017

Keywords provided by Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ):
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

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site