Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Diagnostic, Treatment	Closed	18 and over	NCI	ACOSOG-Z0360 NCT00042926

Objectives

1. 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.
2. Determine the extent and pattern of disease spread in the nodal bed in these patients.
3. Obtain data on the use of immunohistochemistry to assess nodes in these patients.

Entry 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

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

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

American College of Surgeons Oncology Group

Francisco Civantos, MD, Protocol chair		Ph: 305-243-5276

Registry Information
Official Title		A Trial Of Lymphatic Mapping And Sentinel Node Lymphadenectomy For Patients With T1 Or T2 Clinically N0 Oral Cavity Squamous Cell Carcinoma
Trial Start Date		2002-05-31
Registered in ClinicalTrials.gov		NCT00042926
Date Submitted to PDQ		2002-06-10
Information Last Verified		2006-03-22
NCI Grant/Contract Number		CA76001

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