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Diagnostic Trial in Patients Who Are Undergoing Surgery for Early Stage Mouth Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00042926
First received: August 5, 2002
Last updated: November 24, 2010
Last verified: March 2006
  Purpose

RATIONALE: Diagnostic procedures to detect cancer cells in sentinel lymph nodes may help plan effective cancer treatment.

PURPOSE: Diagnostic trial to study the effectiveness of lymph node mapping and sentinel lymph node lymphadenectomy in patients who are undergoing surgery to remove early-stage cancer of the mouth.


Condition Intervention
Head and Neck Cancer
Other: immunohistochemistry staining method
Procedure: conventional surgery
Procedure: lymphangiography
Procedure: radionuclide imaging
Procedure: sentinel lymph node biopsy
Radiation: technetium Tc 99m sulfur colloid

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Trial Of Lymphatic Mapping And Sentinel Node Lymphadenectomy For Patients With T1 Or T2 Clinically N0 Oral Cavity Squamous Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 2002
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine whether a negative hematoxylin and eosin finding from the lymphatic mapping and sentinel node lymphadenectomy procedure accurately predicts the negativity of the other cervical lymph nodes in patients with stage I or II squamous cell carcinoma of the oral cavity.
  • Determine the extent and pattern of disease spread in the nodal bed in these patients.
  • Obtain data on the use of immunohistochemistry to assess nodes in these patients.

OUTLINE: This is a multicenter study.

Patients undergo radiolymphoscintigraphy comprising technetium Tc 99m sulfur colloid to identify the sentinel lymph nodes (SNL). Within 18 hours after radiolymphoscintigraphy, patients undergo resection of the primary oral cavity tumor and radioguided sentinel lymphadenectomy and regional cervical lymphadenectomy. Lymph nodes are examined by hematoxylin and eosin (H&E) staining. If negative by H&E, lymph nodes are further analyzed by immunohistochemistry.

Patients are followed at 30 days.

PROJECTED ACCRUAL: A total of 161 patients will be accrued for this study within 2.7 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary invasive squamous cell carcinoma of the oral cavity

    • T1 or T2 disease
    • At least 6 mm and no greater than 4 cm in size
    • Amenable to curative resection
    • Diagnosed within 60 days prior to surgery
  • Clinical stage N0 confirmed by negative result from contrast-enhanced CT scan or gadolinium-enhanced MRI

    • Lymph nodes considered positive if:

      • Greater than 1.5 cm for levels I and II
      • Greater than 1 cm for levels III, IV, V, and VI
      • Any lymph node exhibits central necrosis or irregular enhancement of a poorly defined or irregular capsular border OR
      • Groups of 3 or more asymmetrically located lymph nodes, with a minimal axial diameter of 8 mm or more, are present in the suspected tumor drainage area
  • No oral malignancy crossing the vermilion border involving the lip skin

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • No prior extensive trauma to the anterior cervical region of the neck
  • Medically fit for neck dissection
  • Prior malignancy allowed provided patient meets the following criteria:

    • Underwent potentially curative therapy for all prior malignancies and is deemed at low risk for recurrence
    • No malignancy for the past 5 years (except effectively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix effectively treated with surgery alone, lobular carcinoma in situ of the ipsilateral or contralateral breast treated with surgery alone, or carcinoma of the mouth that is in situ or minimally invasive) and no evidence of recurrence
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy to cervical lymph nodes

Surgery

  • See Disease Characteristics
  • No prior surgery to cervical lymph nodes
  • No prior tumor resection involving the neck

Other

  • No other nuclear medicine imaging study with fludeoxyglucose F 18 within the past 24 hours
  • No other nuclear medicine imaging study with technetium Tc 99 within the past 48 hours
  • No other nuclear medicine imaging study with iodine I 123 within the past 96 hours
  • No other nuclear medicine imaging study with T1-201 or gadolinium Ga 67 within the past 2 weeks
  • No other nuclear medicine imaging study with iodine I 131 within the past 2 months
  • No other prior therapy to cervical lymph nodes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042926

Sponsors and Collaborators
American College of Surgeons
Investigators
Study Chair: Francisco Civantos, MD University of Miami Sylvester Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00042926     History of Changes
Other Study ID Numbers: CDR0000069485, ACOSOG-Z0360
Study First Received: August 5, 2002
Last Updated: November 24, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I squamous cell carcinoma of the lip and oral cavity
stage II squamous cell carcinoma of the lip and oral cavity

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Technetium Tc 99m Sulfur Colloid
Diagnostic Uses of Chemicals
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiopharmaceuticals

ClinicalTrials.gov processed this record on November 20, 2014