Diagnostic Trial in Patients Who Are Undergoing Surgery for Early Stage Mouth Cancer
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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 |
Other: immunohistochemistry staining method Procedure: conventional surgery Procedure: lymphangiography Procedure: radionuclide imaging Procedure: sentinel lymph node biopsy Radiation: technetium Tc 99m sulfur colloid |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Diagnostic |
| 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 Start Date: | May 2002 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
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 |
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 More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00042926 History of Changes |
| Other Study ID Numbers: | CDR0000069485, ACOSOG-Z0360 |
| Study First Received: | August 5, 2002 |
| Last Updated: | November 24, 2010 |
| 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 |
Additional relevant MeSH terms:
|
Carcinoma, Squamous Cell Head and Neck Neoplasms Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Neoplasms by Site |
ClinicalTrials.gov processed this record on May 19, 2013