Vulvar Cancer Clinical Trial
Official title:
Intraoperative Lymphatic Mapping in Patients With Stage I and II Squamous Carcinoma of the Vulva
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.
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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