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.
