Lymphatic Mapping in Treating Patients With Stage I or Stage II Cancer of the Vulva
Summary
RATIONALE: Lymphatic mapping may improve the ability to detect cancer of the vulva.
PURPOSE: This phase III trial is studying how well lymphatic mapping works in treating patients with stage I or stage II cancer of the vulva.
Description
OBJECTIVES:
- Determine the negative predictive value of a negative sentinel lymph node in patients with invasive squamous cell carcinoma of the vulva.
- Determine the location of the sentinel node in these patients.
OUTLINE: Patients receive injection(s) of isosulfan blue into the dermis at the junction of the tumor and normal vulvar skin. Once the afferent lymphatic channel and sentinel node have been identified, patients undergo unilateral or bilateral inguinal-femoral lymphadenectomy followed by resection of the primary tumor with adequate margins. Preoperative lymphoscintigraphy is also performed.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter or until recurrence.
PROJECTED ACCRUAL: A total of 40-630 patients will be accrued for this study within 2-6 years.
Study Design
Primary Purpose: Treatment
Conditions
Vulvar Cancer
Intervention
isosulfan blue, conventional surgery, sentinel lymph node biopsy
Location
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock
Arkansas
United States
72205
Status
Completed
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00003325
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Sentinel Lymph Node Biopsy
A diagnostic procedure used to determine whether LYMPHATIC METASTASIS has occurred. The sentinel lymph node is the first lymph node to receive drainage from a neoplasm.
Lymph Node Excision
Surgical excision of one or more lymph nodes. Its most common use is in cancer surgery. (From Dorland, 28th ed, p966)
Lymphoma, Follicular
Malignant lymphoma in which the lymphomatous cells are clustered into identifiable nodules within the LYMPH NODES. The nodules resemble to some extent the GERMINAL CENTER of lymph node follicles and most likely represent neoplastic proliferation of lymph node-derived follicular center B-LYMPHOCYTES.
Local Lymph Node Assay
The local lymph node assay (LLNA) is an alternative method for the identification of chemicals that have the ability to cause skin sensitization and allergic contact dermatitis. Endpoints have been established so fewer animals are required and less painful procedures are used.
King's Evil
The historic designation for scrofula (TUBERCULOSIS, LYMPH NODE). The disease is so called from the belief that it could be healed by the touch of a king. This term is used only for historical articles using the name "king's evil", and is to be differentiated from scrofula as lymph node tuberculosis in modern clinical medicine. (From Webster, 3d ed)
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