Diagnostic Trial in Patients Who Are Undergoing Surgery for Early Stage Mouth Cancer - Full Text View

Sponsors and Collaborators:	American College of Surgeons National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00042926

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	Drug: technetium Tc 99m sulfur colloid Procedure: conventional surgery Procedure: immunohistochemistry staining method Procedure: lymphangiography Procedure: radionuclide imaging Procedure: sentinel lymph node biopsy

MedlinePlus related topics: Cancer Head and Neck Cancer Nuclear Scans Oral Cancer

U.S. FDA Resources

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

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

Study Start Date:

May 2002

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

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

Sponsors and Collaborators

American College of Surgeons

National Cancer Institute (NCI)

Investigators

Study Chair:

Francisco Civantos, MD

Sylvester Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000069485, ACOSOG-Z0360
Study First Received:	August 5, 2002
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00042926
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

Study placed in the following topic categories:

Epidermoid carcinoma
Oral cancer
Squamous cell carcinoma
Head and Neck Neoplasms
Carcinoma, squamous cell
Neoplasms, Squamous Cell

Carcinoma, Squamous Cell
Mouth Neoplasms
Dental Caries
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 13, 2009