Lymphatic Mapping in Treating Patients With Stage I or Stage II Cancer of the Vulva
- Conditions
- Vulvar Cancer
- Interventions
- Procedure: Sentinel lymph node mapping
- 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
- Arm && Interventions
Group Intervention Description Sentinenal lymph node mapping Sentinel lymph node mapping Sentinenal lymph node mapping
- 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)
Elkhart General Hospital
🇺🇸Elkhart, Indiana, United States
Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
🇺🇸Baltimore, Maryland, United States
Tufts-NEMC Cancer Center
🇺🇸Boston, Massachusetts, United States
Cleveland Clinic Cancer Center at Fairview Hospital
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Fox Chase Cancer Center - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
UPMC Cancer Center at Magee-Womens Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Indiana University Melvin and Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
St. Vincent Indianapolis Hospital
🇺🇸Indianapolis, Indiana, United States
Masonic Cancer Center at University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
Helen and Harry Gray Cancer Center at Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Todd Cancer Institute at Long Beach Memorial Medical Center
🇺🇸Long Beach, California, United States
Hinsdale Hematology Oncology Associates
🇺🇸Hinsdale, Illinois, United States
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Gynecologic Oncology of Indiana
🇺🇸Indianapolis, Indiana, United States
CCOP - Northern Indiana CR Consortium
🇺🇸South Bend, Indiana, United States
Saint Joseph Regional Medical Center
🇺🇸South Bend, Indiana, United States
Howard Community Hospital
🇺🇸Kokomo, Indiana, United States
South Bend Clinic
🇺🇸South Bend, Indiana, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
Maine Medical Center - Bramhall Campus
🇺🇸Portland, Maine, United States
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
LDS Hospital
🇺🇸Salt Lake City, Utah, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
Lake/University Ireland Cancer Center
🇺🇸Mentor, Ohio, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
M. D. Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Riverside Methodist Hospital Cancer Care
🇺🇸Columbus, Ohio, United States
Oklahoma University Cancer Institute
🇺🇸Oklahoma City, Oklahoma, United States
Lakeland Regional Cancer Care Center - St. Joseph
🇺🇸St. Joseph, Michigan, United States
Cancer Care Associates - Saint Francis Campus
🇺🇸Tulsa, Oklahoma, United States
St. John's Regional Health Center
🇺🇸Springfield, Missouri, United States
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
🇺🇸Voorhees, New Jersey, United States
Hope A Women's Cancer Center
🇺🇸Asheville, North Carolina, United States
Aultman Cancer Center at Aultman Hospital
🇺🇸Canton, Ohio, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
🇺🇸Saint Louis, Missouri, United States
Sanford Cancer Center at Sanford USD Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Baptist Centers for Cancer Care
🇺🇸Memphis, Tennessee, United States
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
🇺🇸New Britain, Connecticut, United States
Parkland Memorial Hospital
🇺🇸Dallas, Texas, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
🇺🇸Marlton, New Jersey, United States
Women's Cancer Center - Lake Mead
🇺🇸Las Vegas, Nevada, United States
University of Virginia Cancer Center
🇺🇸Charlottesville, Virginia, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Hulston Cancer Center at Cox Medical Center South
🇺🇸Springfield, Missouri, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
🇺🇸Allentown, Pennsylvania, United States
Borgess Medical Center
🇺🇸Kalamazoo, Michigan, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
UT Southwestern University Hospital - Zale Lipshy
🇺🇸Dallas, Texas, United States
Gundersen Lutheran Center for Cancer and Blood
🇺🇸La Crosse, Wisconsin, United States
Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Mount Carmel Health - West Hospital
🇺🇸Columbus, Ohio, United States
Hillcrest Cancer Center at Hillcrest Hospital
🇺🇸Mayfield Heights, Ohio, United States
Waukesha Memorial Hospital Regional Cancer Center
🇺🇸Waukesha, Wisconsin, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
Wake Forest University Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Carilion Gynecologic Oncology Associates
🇺🇸Roanoke, Virginia, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
🇺🇸Hartford, Connecticut, United States
Washington Cancer Institute at Washington Hospital Center
🇺🇸Washington, District of Columbia, United States