Status and phase
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About
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.
Full description
OBJECTIVES:
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.
Enrollment
Sex
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed invasive squamous cell carcinoma of the vulva that is greater than 1 mm in thickness as measured from the nearest rete peg
Prior excision of the primary disease or a history of carcinoma in situ of the vulva allowed
No tumor extending into the urethra, anus, vagina, rectum, or bladder
No grossly suspicious or inflamed groin nodes on physical exam
No grossly infected primary tumors
PATIENT CHARACTERISTICS:
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Surgery:
Primary purpose
Allocation
Interventional model
Masking
515 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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