Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Projected Accrual
Outline
Trial Contact Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Diagnostic, Treatment Active Any age NCI GOG-173

Special Category: NIH Clinical Center trial

Objectives

1. Determine the negative predictive value of a negative sentinel lymph node in patients with invasive squamous cell carcinoma of the vulva.
2. Determine the location of the sentinel node in these patients.

Entry 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

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

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

Projected Accrual

A total of 40-630 patients will be accrued for this study within 2-6 years.

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 and intraoperative 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.

Disclaimer

The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

The study sites listed for this clinical trial are potential study sites; however, not all sites may be participating.

Trial Contact Information

Trial Lead Organizations

Gynecologic Oncology Group

Charles Levenback, MD, Protocol chair		Ph: 713-745-2563; 800-392-1611 Email: clevenba@mdanderson.org
Robert Coleman, MD, Protocol co-chair		Ph: 214-648-3026 Email: Robert.Coleman@UTSouthwestern.edu
Benjamin E. Greer, MD, Protocol co-chair		Ph: 206-685-2463

U.S.A.
Alabama
	Birmingham
	University of Alabama at Birmingham Comprehensive Cancer Center
		Mack Barnes, MD	Ph:  205-934-5077
Arizona
	Phoenix
	CCOP - Western Regional, Arizona
		David King, MD, FACP	Ph:  602-239-2413
			Email: david.king@baannerhealth.com
California
	Los Gatos
	Women's Cancer Center at Community Hospital of Los Gatos
		Nick Spirtos, MD	Ph:  408-866-3843
			Email: nspirtos@wccenter.com
	Orange
	Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
		Robert Burger, MD	Ph:  714-456-7971
			Email: raburger@uci.edu
Colorado
	Denver
	University of Colorado Cancer Center at University of Colorado Health Sciences Center
		Francis Major, MD	Ph:  303-388-4876 800-473-2288
			Email: francis.major@usoncology.com
Delaware
	Newark
	CCOP - Christiana Care Health Services
		Stephen Grubbs, MD	Ph:  302-623-4100
Florida
	Tampa
	H. Lee Moffitt Cancer Center and Research Institute
		James V. Fiorica, MD	Ph:  813-972-8478
			Email: fiorica@moffitt.usf.edu
Illinois
	Chicago
	MBCCOP - University of Illinois at Chicago
		Lawrence Feldman, MD	Ph:  312-335-3614
	Decatur
	CCOP - Central Illinois
		L. Massad, MD	Ph:  217-545-8882
	Evanston
	CCOP - Evanston
		Gershon Locker, MD, FACP	Ph:  847-570-2518
			Email: glocker@enh.org
	Urbana
	CCOP - Carle Cancer Center
		Kendrith Rowland, MD	Ph:  217-383-4083
			Email: kendrith.rowland@carle.com
Indiana
	Indianapolis
	Indiana University Cancer Center
		Katherine Look, MD	Ph:  317-274-8987 888-600-4822
			Email: klook@iupui.edu
	South Bend
	Saint Joseph Regional Medical Center
		Michael Method, MD, MPH	Ph:  574-237-8010
			Email: mmethod@mhopc.com
Iowa
	Iowa City
	Holden Comprehensive Cancer Center at University of Iowa
		Joel Sorosky, MD	Ph:  319-356-2015
			Email: joel-sorosky@uiowa.edu
Maryland
	Bethesda
	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
		NCI Clinical Studies Support	Ph:  888-NCI-1937
Massachusetts
	Boston
	Tufts - New England Medical Center
		Kenneth Noller, MD	Ph:  617-636-2382
Michigan
	Ann Arbor
	CCOP - Michigan Cancer Research Consortium
		Philip Stella, MD	Ph:  877-590-5995
			Email: beekmanl@trinity-health
	Grand Rapids
	CCOP - Grand Rapids
		Kathleen Yost, MD	Ph:  616-391-1230
			Email: kathleen.yost@grcop.org
	Kalamazoo
	CCOP - Kalamazoo
		Raymond Lord, MD	Ph:  269-373-7488
			Email: rlord@wmcc.org
Minnesota
	Minneapolis
	University of Minnesota Cancer Center
		Linda Carson, MD	Ph:  612-626-3347 888-226-2376
			Email: carso001@umn.edu
	Rochester
	Mayo Clinic Cancer Center
		Harry J. Long, MD	Ph:  507-284-2511
	Saint Louis Park
	CCOP - Metro-Minnesota
		Patrick Flynn, MD	Ph:  952-993-1517
			Email: patrick.flynn@usoncology.com
Mississippi
	Jackson
	University of Mississippi Medical Center
		James Thigpen, MD	Ph:  601-984-5590
			Email: jthigpen@medicine.umsmed.edu
	Keesler AFB
	Keesler Medical Center - Keesler Air Force Base
		John Bomalaski, MD	Ph:  228-377-6396
			Email: john.bomalaski@keesler.af.mil
Missouri
	Columbia
	Ellis Fischel Cancer Center at University of Missouri - Columbia
		Sara Crowder, MD	Ph:  573-882-1057
			Email: crowders@health.missouri.edu
	Kansas City
	CCOP - Kansas City
		Jorge Paradelo, MD	Ph:  816-823-0555
			Email: kccop@kccop.org
	Saint Louis
	Siteman Cancer Center
		David Mutch, MD	Ph:  314-362-3181 800-600-3606
	Springfield
	CCOP - Cancer Research for the Ozarks
		John Goodwin, MD	Ph:  417-269-4520
			Email: jwg684@sprg.mercy.net
Nebraska
	Omaha
	CCOP - Missouri Valley Cancer Consortium
		James Mailliard, MD	Ph:  402-280-4364
			Email: jamailliard@mrcc.cc
New Jersey
	Camden
	Cooper University Hospital
		David Warshal, MD	Ph:  856-342-2185 800-8-COOPER
			Email: warshal-david@cooperhealth.edu
New York
	Buffalo
	Roswell Park Cancer Institute
		Shashikant B. Lele, MD	Ph:  716-845-5776 800-767-9355
			Email: shashi.lele@roswellpark.org
	New York
	Memorial Sloan-Kettering Cancer Center
		Carol L. Brown, MD	Ph:  212-639-7659
North Carolina
	Chapel Hill
	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
		Wesley Fowler, MD	Ph:  919-966-1196
			Email: wfowler@med.unc.edu
	Durham
	Duke Comprehensive Cancer Center
		Daniel Clarke-Pearson, MD	Ph:  919-684-3765
	Winston-Salem
	Comprehensive Cancer Center at Wake Forest University
		Brigitte Miller, MD	Ph:  336-716-6673
			Email: bemiller@wfubmc.edu
Ohio
	Cincinnati
	Charles M. Barrett Cancer Center at University Hospital
		Nader Husseinzadeh, MD	Ph:  513-558-8450
			Email: nallerhusseinzadeh@uc.edu
	Cleveland
	Cleveland Clinic Taussig Cancer Center
		Peter Rose, MD	Ph:  216-444-1712
			Email: rosep@ccf.org
	Ireland Cancer Center
		Steven Waggoner, MD	Ph:  216-844-5011 800-641-2422
	Columbus
	Arthur G. James Cancer Hospital at Ohio State University
		Jeffrey Fowler, MD	Ph:  614-293-8737 800-293-5066
Oklahoma
	Oklahoma City
	University of Oklahoma College of Medicine
		Robert Mannel, MD	Ph:  405-271-8787
			Email: robert-mannel@ouhsc.edu
Oregon
	Portland
	CCOP - Columbia River Oncology Program
		Keith Lanier, MD	Ph:  503-216-6260
Pennsylvania
	Abington
	Abington Memorial Hospital
		Parviz Hanjani, MD	Ph:  215-885-0220
			Email: phanjani@amh.org
	Danville
	CCOP - Geisinger Clinic and Medical Center
		Nava Siegelmann-Danieli, MD	Ph:  570-271-6834
			Email: nsdanieli@geisinger.edu
	Hershey
	Penn State Cancer Institute at Milton S. Hershey Medical Center
		George Olt, MD	Ph:  717-531-8144
	Philadelphia
	Abramson Cancer Center of the University of Pennsylvania Medical Center
		Mark Morgan, MD	Ph:  215-662-6043
	Fox Chase Cancer Center
		Michael Bookman, MD	Ph:  215-728-2987 888-369-2571
			Email: ma_bookman@fccc.edu
	Pittsburgh
	UPMC Cancer Center at Magee-Womens Hospital
		Joseph Kelley, MD	Ph:  412-641-5418
			Email: jkelley@mail.magee.edu
Tennessee
	Knoxville
	Southeast Gynecologic Oncology Associates
		Kenneth Cofer, MD	Ph:  865-673-9250
	Nashville
	Gynecologic Oncology Network
		Howard Homesley, MD	Ph:  615-804-2216
			Email: hdh7173@aol.com
	Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
		Marta Crispens, MD	Ph:  615-322-2114 800-811-8480
			Email: marta.crispens@vanderbilt.edu
Texas
	Dallas
	Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
		David Miller, MD	Ph:  214-648-3026
			Email: david.miller@utsouthwestern.edu
	Galveston
	University of Texas Medical Branch
		Edward Hannigan, MD	Ph:  409-772-3368
			Email: edward.hanniga@utmb.edu
	Houston
	University of Texas - MD Anderson Cancer Center
		Charles Levenback, MD	Ph:  713-745-2563 800-392-1611
			Email: clevenba@mdanderson.org
	Temple
	CCOP - Scott and White Hospital
		Lucas Wong, MD	Ph:  254-724-1053
			Email: lwong@swmail.sw.org
Vermont
	Burlington
	Fletcher Allen Health Care - Medical Center Campus
		Cheung Wong, MD	Ph:  802-847-5110
			Email: cheung.wong@vtmednet.org
Virginia
	Charlottesville
	Cancer Center at the University of Virginia
		Willie Albert Andersen, MD	Ph:  434-924-9333 800-223-9173
Washington
	Seattle
	Fred Hutchinson Cancer Research Center
		Benjamin E. Greer, MD	Ph:  206-685-2463
	University Cancer Center at University of Washington Medical Center
		Benjamin E. Greer, MD	Ph:  206-685-2463
			Email: bengreer@u.washington.edu
Wisconsin
	Madison
	University of Wisconsin Comprehensive Cancer Center
		Ellen Hartenbach, MD	Ph:  608-263-1209 800-622-8922
Norway
	Oslo
	Norwegian Radium Hospital
		Gunnar Kristensen, MD, PhD	Ph:  47-22-934-000
			Email: gunnar.kristensen@klinmed.uio.no

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