Lymphatic Mapping in Treating Patients With Stage I or Stage II Cancer of the Vulva - Full Text View

Sponsor:	Gynecologic Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003325

Purpose

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.

Condition	Intervention	Phase
Vulvar Cancer	Drug: isosulfan blue Procedure: conventional surgery Procedure: sentinel lymph node biopsy	Phase III

Study Type:	Interventional
Study Design:	Treatment
Official Title:	Intraoperative Lymphatic Mapping in Patients With Stage I and II Squamous Carcinoma of the Vulva

Resource links provided by NLM:

MedlinePlus related topics: Cancer Vulvar Cancer

Drug Information available for: Iso-sulfan blue

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Disease status [ Designated as safety issue: No ]
Tumor characteristics (e.g., stage, clinical tumor size, status of the capillary/lymphatic spaces, and histologic type of tumor) [ Designated as safety issue: No ]
Host characteristics (e.g., age and performance status) [ Designated as safety issue: No ]
Adverse effects of the mapping procedure and dissection (i.e., frequency and severity) [ Designated as safety issue: Yes ]

Estimated Enrollment:	630
Study Start Date:	December 1999
Estimated Primary Completion Date:	November 2001 (Final data collection date for primary outcome measure)

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003325

Hide Study Locations

Locations

United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Todd Cancer Institute at Long Beach Memorial Medical Center
Long Beach, California, United States, 90801
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, Connecticut
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
New Britain, Connecticut, United States, 06050
Helen and Harry Gray Cancer Center at Hartford Hospital
Hartford, Connecticut, United States, 06102-5037
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
United States, District of Columbia
Washington Cancer Institute at Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Georgia
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403-3089
United States, Illinois
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States, 60153
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States, 60521
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Gynecologic Oncology of Indiana
Indianapolis, Indiana, United States, 46237
Saint Joseph Regional Medical Center
South Bend, Indiana, United States, 46617
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202-5289
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Howard Community Hospital
Kokomo, Indiana, United States, 46904
South Bend Clinic
South Bend, Indiana, United States, 46617
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, United States, 46260
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
United States, Maine
Maine Medical Center - Bramhall Campus
Portland, Maine, United States, 04102
United States, Maryland
Harry & Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
United States, Massachusetts
Tufts-NEMC Cancer Center
Boston, Massachusetts, United States, 02111
United States, Michigan
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Lakeland Regional Cancer Care Center - St. Joseph
St. Joseph, Michigan, United States, 49085
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
United States, Minnesota
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Missouri
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Saint Louis, Missouri, United States, 63110
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
United States, Nevada
Women's Cancer Center - Lake Mead
Las Vegas, Nevada, United States, 89102
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees, New Jersey, United States, 08043
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States, 08053
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, North Carolina
Hope A Women's Cancer Center
Asheville, North Carolina, United States, 28801
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, Ohio
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267
Aultman Cancer Center at Aultman Hospital
Canton, Ohio, United States, 44710-1799
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210-1240
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, United States, 44111
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States, 44124
Lake/University Ireland Cancer Center
Mentor, Ohio, United States, 44060
Mount Carmel Health - West Hospital
Columbus, Ohio, United States, 43222
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
United States, Oklahoma
Cancer Care Associates - Saint Francis Campus
Tulsa, Oklahoma, United States, 74136-1929
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States, 18105
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
UPMC Cancer Center at Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Tennessee
Baptist Centers for Cancer Care
Memphis, Tennessee, United States, 38120
United States, Texas
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Parkland Memorial Hospital
Dallas, Texas, United States, 75235
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
UT Southwestern University Hospital - Zale Lipshy
Dallas, Texas, United States, 75235
United States, Utah
LDS Hospital
Salt Lake City, Utah, United States, 84103
United States, Virginia
Carilion Gynecologic Oncology Associates
Roanoke, Virginia, United States, 24014
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
United States, Wisconsin
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, United States, 53188

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Charles Levenback, MD	M.D. Anderson Cancer Center
Investigator:	Benjamin E. Greer, MD	Fred Hutchinson Cancer Research Center

Responsible Party:	Gynecologic Oncology Group ( Philip J. DiSaia )
Study ID Numbers:	CDR0000066277, GOG-173
Study First Received:	November 1, 1999
Last Updated:	July 20, 2009
ClinicalTrials.gov Identifier:	NCT00003325 History of Changes
Health Authority:	United States: Federal Government