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


N/A
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Diagnostic

Principal Investigator

Francisco Civantos, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000069485

NCT ID:

NCT00042926

Start Date:

May 2002

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • stage I squamous cell carcinoma of the lip and oral cavity
  • stage II squamous cell carcinoma of the lip and oral cavity
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

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