Lymphatic Mapping in Treating Patients With Stage I or Stage II Cancer of the Vulva
NCT ID: NCT00003325
Last Updated: 2015-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
515 participants
INTERVENTIONAL
1999-12-31
Brief Summary
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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.
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Detailed Description
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* 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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Sentinenal lymph node mapping
Sentinenal lymph node mapping
Sentinel lymph node mapping
Sentinel lymph node mapping
Interventions
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Sentinel lymph node mapping
Sentinel lymph node mapping
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed invasive squamous cell carcinoma of the vulva that is greater than 1 mm in thickness as measured from the nearest rete peg
* Tumor size must be 2-6 cm
* No recurrent disease
* Prior excision of the primary disease or a history of carcinoma in situ of the vulva allowed
* No tumor extending into the urethra, anus, vagina, rectum, or bladder
* No grossly suspicious or inflamed groin nodes on physical exam
* No grossly infected primary tumors
PATIENT CHARACTERISTICS:
Age:
* Any age
Performance status:
* GOG 0-3
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* No other invasive malignancy within the past 5 years except non-melanomatous skin cancer
* No known hypersensitivity to phenylethane compounds
PRIOR CONCURRENT THERAPY:
* No prior cancer therapy that contraindicates therapy in this study
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* See Disease Characteristics
* No prior groin dissection
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Charles Levenback, MD
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Locations
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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 D.C., 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
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Gynecologic Oncology of Indiana
Indianapolis, Indiana, United States
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, United States
Howard Community Hospital
Kokomo, Indiana, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Saint Joseph Regional Medical Center
South Bend, 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
Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
Baltimore, Maryland, United States
Tufts-NEMC Cancer Center
Boston, Massachusetts, United States
Borgess Medical Center
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, United States
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
St. John's Regional Health Center
Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
St Louis, Missouri, United States
Women's Cancer Center - Lake Mead
Las Vegas, Nevada, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees Township, New Jersey, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Hope A Women's Cancer Center
Asheville, North Carolina, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Aultman Cancer Center at Aultman Hospital
Canton, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 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
Mount Carmel Health - West Hospital
Columbus, Ohio, United States
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States
Lake/University Ireland Cancer Center
Mentor, Ohio, United States
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States
Cancer Care Associates - Saint Francis Campus
Tulsa, Oklahoma, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States
UPMC Cancer Center at Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States
Baptist Centers for Cancer Care
Memphis, Tennessee, United States
Parkland Memorial Hospital
Dallas, Texas, United States
UT Southwestern University Hospital - Zale Lipshy
Dallas, Texas, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
LDS Hospital
Salt Lake City, Utah, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
Carilion Gynecologic Oncology Associates
Roanoke, Virginia, United States
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, United States
Countries
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References
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Levenback CF, Ali S, Coleman RL, Gold MA, Fowler JM, Judson PL, Bell MC, De Geest K, Spirtos NM, Potkul RK, Leitao MM Jr, Bakkum-Gamez JN, Rossi EC, Lentz SS, Burke JJ 2nd, Van Le L, Trimble CL. Lymphatic mapping and sentinel lymph node biopsy in women with squamous cell carcinoma of the vulva: a gynecologic oncology group study. J Clin Oncol. 2012 Nov 1;30(31):3786-91. doi: 10.1200/JCO.2011.41.2528. Epub 2012 Jul 2.
Levenback CF, Tian C, Coleman RL, et al.: Sentinel node (SN) biopsy in patients with vulvar cancer: A Gynecologic Oncology Group (GOG) study. [Abstract] J Clin Oncol 27 (Suppl 15): A-5505, 2009.
Other Identifiers
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CDR0000066277
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2009-00579
Identifier Type: OTHER
Identifier Source: secondary_id
GOG-0173
Identifier Type: -
Identifier Source: org_study_id
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