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	Treatment or Intervention
stage I squamous cell carcinoma of the lip and oral cavity stage II squamous cell carcinoma of the lip and oral cavity	Drug: technetium Tc 99m sulfur colloid  Procedure: conventional surgery  Procedure: diagnostic test  Procedure: immunohistochemistry  Procedure: lymphography  Procedure: radionuclide imaging  Procedure: sentinel node biopsy  Procedure: surgery

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Alabama
      University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham,  Alabama,  35294-3300,  United States; Recruiting
Arkansas
      Arkansas Cancer Research Center at University of Arkansas for Medical Sciences, Little Rock,  Arkansas,  72205,  United States; Recruiting
Florida
      H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa,  Florida,  33612-9497,  United States; Recruiting
      University of Miami Sylvester Comprehensive Cancer Center, Miami,  Florida,  33136,  United States; Recruiting
      Watson Clinic, Lakeland,  Florida,  33804-5000,  United States; Recruiting
Georgia
      MBCCOP-Medical College of Georgia Cancer Center, Augusta,  Georgia,  30912-4000,  United States; Recruiting
Illinois
      Cancer Institute at St. John's Hospital, Springfield,  Illinois,  62701,  United States; Recruiting
      Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood,  Illinois,  60153,  United States; Recruiting
      Evanston Northwestern Health Care - Evanston Hospital, Evanston,  Illinois,  60201,  United States; Recruiting
      Regional Cancer Center at Memorial Medical Center, Springfield,  Illinois,  62781,  United States; Recruiting
      Southern Illinois University School of Medicine, Springfield,  Illinois,  62794-9230,  United States; Recruiting
Iowa
      University of Iowa Hospitals and Clinics, Iowa City,  Iowa,  52242-1083,  United States; Recruiting
Kentucky
      Markey Cancer Center at University of Kentucky Chandler Medical Center, Lexington,  Kentucky,  40536-0084,  United States; Recruiting
Michigan
      Great Lakes Cancer Institute at McLaren Regional Medical Center, Flint,  Michigan,  48532,  United States; Recruiting
Mississippi
      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States; Recruiting
Missouri
      Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia,  Missouri,  65203,  United States; Recruiting
      Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis,  Missouri,  63110-1093,  United States; Recruiting
New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting
Ohio
      Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus,  Ohio,  43210-1240,  United States; Recruiting
Oregon
      Cancer Institute at Oregon Health and Science University, Portland,  Oregon,  97239-3098,  United States; Recruiting
Pennsylvania
      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111-2497,  United States; Recruiting
      Penn State Cancer Institute at Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033-0850,  United States; Recruiting
      UPMC Cancer Center at UPMC Presbyterian, Pittsburgh,  Pennsylvania,  15213,  United States; Recruiting
South Carolina
      Hollings Cancer Center at Medical University of South Carolina, Charleston,  South Carolina,  29425,  United States; Recruiting
Tennessee
      Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville,  Tennessee,  37232-6838,  United States; Recruiting
Texas
      Baylor University Medical Center, Dallas,  Texas,  75246,  United States; Recruiting
      MD Anderson Cancer Center at University of Texas, Houston,  Texas,  77030-4009,  United States; Recruiting
Utah
      American Fork Hospital, American Fork,  Utah,  84003,  United States; Recruiting
      LDS Hospital, Salt Lake City,  Utah,  84143,  United States; Recruiting
Washington
      Veterans Affairs Medical Center - Seattle, Seattle,  Washington,  98108,  United States; Recruiting
West Virginia
      Mary Babb Randolph Cancer Center at West Virginia University Hospitals, Morgantown,  West Virginia,  26506-9300,  United States; Recruiting
Canada, Manitoba
      CancerCare Manitoba, Winnipeg,  Manitoba,  R3E 0V9,  Canada; Recruiting

Study chairs or principal investigators

Francisco Civantos, MD,  Study Chair,  Sylvester Cancer Center   

Study ID Numbers:  CDR0000069485; ACOSOG-Z0360; NCT00042926
Record last reviewed:  September 2004
Last Updated:  February 4, 2005
Record first received:  August 5, 2002
ClinicalTrials.gov Identifier:  NCT00042926
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08