NCT00003325

Lymphatic Mapping in Treating Patients With Stage I or Stage II Cancer of the Vulva

Intraoperative Lymphatic Mapping in Patients With Stage I and II Squamous Carcinoma of the Vulva

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 515 (actual)
• Sponsor: Gynecologic Oncology Group · Network
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Vulvar Cancer

Interventions

Type	Name	Description
PROCEDURE	Sentinel lymph node mapping	Sentinel lymph node mapping

Timeline

• Start date: 1999-12-01
• Primary completion: 2013-07-01
• First posted: 2003-01-27
• Last updated: 2015-05-29

Locations

72 sites across 1 country: United States