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

Condition(s) targeted: Head and Neck Cancer

Intervention: technetium Tc 99m sulfur colloid (Drug); conventional surgery (Procedure); diagnostic procedure (Procedure); immunohistochemistry staining method (Procedure); lymphangiography (Procedure); radionuclide imaging (Procedure); sentinel lymph node biopsy (Procedure)

Phase: N/A

Status: Active, not recruiting

Sponsored by: American College of Surgeons

Official(s) and/or principal investigator(s):
Francisco Civantos, MD, Study Chair, Affiliation: University of Miami Sylvester Comprehensive Cancer Center - Miami

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.

Official title: A Trial Of Lymphatic Mapping And Sentinel Node Lymphadenectomy For Patients With T1 Or T2 Clinically N0 Oral Cavity Squamous Cell Carcinoma

Study design: Diagnostic, Open Label

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): 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

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: May 2002
Last updated: December 1, 2007