Lymphatic Mapping in Treating Patients With Stage I or Stage II Cancer of the Vulva
- Conditions
- Vulvar Cancer
- Registration Number
- NCT00003325
- Lead Sponsor
- Gynecologic Oncology Group
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 515
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Predictive value of negative sentinel lymph nodes in vulvar cancer patients at time of surgery
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (72)
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Todd Cancer Institute at Long Beach Memorial Medical Center
🇺🇸Long Beach, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
Helen and Harry Gray Cancer Center at Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
🇺🇸Hartford, Connecticut, United States
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
🇺🇸New Britain, Connecticut, United States
Washington Cancer Institute at Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
Hinsdale Hematology Oncology Associates
🇺🇸Hinsdale, Illinois, United States
Scroll for more (62 remaining)Arkansas Cancer Research Center at University of Arkansas for Medical Sciences🇺🇸Little Rock, Arkansas, United States