Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry 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 GOG-0173, NCT00003325

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

Expected Enrollment

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

Outcomes

Disease status
Tumor characteristics (e.g., stage, clinical tumor size, status of the capillary/lymphatic spaces, and histologic type of tumor)
Host characteristics (e.g., age and performance status)
Adverse effects of the mapping procedure and dissection (i.e., frequency and severity)

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.

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
Benjamin Greer, MD, Protocol co-chair		Ph: 206-685-2463

U.S.A.
Arkansas
	Little Rock
	Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
		Clinical Trial Office - Arkansas Cancer Research Center at University of Arkansas for Medical Sciences	Ph:  501-686-8274
California
	Long Beach
	Todd Cancer Institute at Long Beach Memorial Medical Center
		Wendy Brewster, MD, PhD	Ph:  714-456-8020
	San Francisco
	UCSF Helen Diller Family Comprehensive Cancer Center
		Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center	Ph:  877-827-3222
Connecticut
	Hartford
	Helen and Harry Gray Cancer Center at Hartford Hospital
		Clinical Trials Office - Helen and Harry Gray Cancer Center	Ph:  860-545-5363
	Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
		Beth Nelson	Ph:  860-714-4680
	New Britain
	George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
		Clinical Trials Office - George Bray Cancer Center	Ph:  860-224-5660
District of Columbia
	Washington
	Washington Cancer Institute at Washington Hospital Center
		Clinical Trials Office - Washington Cancer Institute	Ph:  202-877-8839
Florida
	Jacksonville
	Mayo Clinic - Jacksonville
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
Georgia
	Savannah
	Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
		Clinical Trials Office - Curtis and Elizabeth Anderson Cancer Institute	Ph:  912-350-8568
Illinois
	Hinsdale
	Hinsdale Hematology Oncology Associates
		Sudarshan Sharma, MD	Ph:  630-856-6757
	Maywood
	Cardinal Bernardin Cancer Center at Loyola University Medical Center
		Clinical Trials Office - Cardinal Bernardin Cancer Center	Ph:  708-226-4357
Indiana
	Elkhart
	Elkhart General Hospital
		Michael Method, MD, MPH	Ph:  574-237-1328
	Indianapolis
	Indiana University Melvin and Bren Simon Cancer Center
		Clinical Trials Office - Indiana University Cancer Center	Ph:  317-274-2552
	St. Vincent Indianapolis Hospital
		Clinical Trials Office - St. Vincent Indianapolis Hospital	Ph:  317-338-2194
	Kokomo
	Howard Community Hospital
		Michael Method, MD, MPH	Ph:  574-237-1328
	South Bend
	CCOP - Northern Indiana CR Consortium
		Michael Method, MD, MPH	Ph:  574-237-1328
	Memorial Hospital of South Bend
		Clinical Trials Office - Memorial Hospital of South Bend	Ph:  800-284-7370
	Saint Joseph Regional Medical Center
		Michael Method, MD, MPH	Ph:  574-237-1328
	South Bend Clinic
		Michael Method, MD, MPH	Ph:  574-237-1328
Iowa
	Iowa City
	Holden Comprehensive Cancer Center at University of Iowa
		Cancer Information Service	Ph:  800-237-1225
Maine
	Portland
	Maine Medical Center - Bramhall Campus
		Clinical Trials Office - Maine Medical Center - Bramhall Campus	Ph:  207-885-7565
Massachusetts
	Boston
	Tufts-NEMC Cancer Center
		Katie Wakeley	Ph:  617-636-6100
Michigan
	Grand Rapids
	Gynecologic Oncology of West Michigan
		Gordon Downey, MD	Ph:  616-957-3398
	Kalamazoo
	Borgess Medical Center
		Raymond Lord, MD	Ph:  269-373-7458
	Bronson Methodist Hospital
		Raymond Lord, MD	Ph:  269-373-7458
	West Michigan Cancer Center
		Clinical Trials Office - West Michigan Cancer Center	Ph:  269-373-7458
	St. Joseph
	Lakeland Regional Cancer Care Center - St. Joseph
		Michael Method, MD, MPH	Ph:  574-237-1328
Minnesota
	Minneapolis
	Masonic Cancer Center at University of Minnesota
		Clinical Trials Office - Masonic Cancer Center at University of Minnesota	Ph:  612-624-2620
	Rochester
	Mayo Clinic Cancer Center
		Clinical Trials Office - All Mayo Clinic Locations	Ph:  507-538-7623
Missouri
	Saint Louis
	Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
		David Mutch, MD	Ph:  314-362-3181
	Springfield
	CCOP - Cancer Research for the Ozarks
		Robert Carolla	Ph:  417-269-4520
	Hulston Cancer Center at Cox Medical Center South
		Robert Carolla	Ph:  417-269-5257
	St. John's Regional Health Center
		Robert Carolla	Ph:  417-820-2000
Nevada
	Las Vegas
	Women's Cancer Center - Lake Mead
		Nick Spirtos, MD	Ph:  408-866-3843
New Hampshire
	Lebanon
	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
		Clinical Trials Office - Norris Cotton Cancer Center	Ph:  603-650-7609
			Email: cancerhelp@dartmouth.edu
New Jersey
	Marlton
	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
		Clinical Trials Office - Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton	Ph:  888-847-8823
	Morristown
	Carol G. Simon Cancer Center at Morristown Memorial Hospital
		Paul Heller, MD	Ph:  973-971-5900
	Voorhees
	Fox Chase Virtua Health Cancer Program at Virtua West Jersey
		Howard Saul, DO	Ph:  856-673-0015
New York
	New York
	Memorial Sloan-Kettering Cancer Center
		Mary Gemignani, MD	Ph:  212-639-6085
North Carolina
	Asheville
	Hope A Women's Cancer Center
		David Hetzel, MD	Ph:  828-670-8403
	Chapel Hill
	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
		Clinical Trials Office - Lineberger Comprehensive Cancer Center	Ph:  877-668-0683; 919-966-4432
	Durham
	Duke Comprehensive Cancer Center
		Clinical Trials Office - Duke Comprehensive Cancer Center	Ph:  888-275-3853
	Winston-Salem
	Wake Forest University Comprehensive Cancer Center
		Clinical Trials Office - Wake Forest University Comprehensive Cancer Center	Ph:  336-713-6771
Ohio
	Canton
	Aultman Cancer Center at Aultman Hospital
		Clinical Trials Office - Aultman Cancer Center at Aultman Hospital	Ph:  330-363-6891
	Cincinnati
	Charles M. Barrett Cancer Center at University Hospital
		Elizabeth Kelly	Ph:  513-584-3200 888-640-CARE
	Cleveland
	Case Comprehensive Cancer Center
		Clinical Trials Office - Case Comprehensive Cancer Center	Ph:  800-641-2422
	Cleveland Clinic Cancer Center at Fairview Hospital
		Clinical Trials Office - Cleveland Clinic Cancer Center at Fairview Hospital	Ph:  216-476-9362
	Cleveland Clinic Taussig Cancer Center
		Clinical Trials Office - Cleveland Clinic Taussig Cancer Center	Ph:  866-223-8100
	Columbus
	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
		Clinical Trials Office - OSU Comprehensive Cancer Center	Ph:  614-293-4976
			Email: osu@emergingmed.com
	Mount Carmel Health - West Hospital
		George Lewandowski, MD	Ph:  614-224-7662
	Riverside Methodist Hospital Cancer Care
		Clinical Trials Office - Riverside Methodist Hospital Cancer Care	Ph:  614-566-4475
	Mayfield Heights
	Hillcrest Cancer Center at Hillcrest Hospital
		Peter Rose, MD	Ph:  216-444-1712
	Mentor
	Lake/University Ireland Cancer Center
		Steven Waggoner, MD	Ph:  216-844-5011
Oklahoma
	Oklahoma City
	Oklahoma University Cancer Institute
		Robert Mannel, MD	Ph:  405-271-8787
	Tulsa
	Cancer Care Associates - Saint Francis Campus
		Robert Mannel, MD	Ph:  405-271-8787
Pennsylvania
	Abington
	Rosenfeld Cancer Center at Abington Memorial Hospital
		Clinical Trials Office - Rosenfeld Cancer Center at Abington Memorial Hospital	Ph:  215-481-2402
	Allentown
	Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
		Richard Boulay, MD	Ph:  610-402-3650
	Philadelphia
	Fox Chase Cancer Center - Philadelphia
		Clinical Trials Office - Fox Chase Cancer Center - Philadelphia	Ph:  215-728-4790
	Pittsburgh
	UPMC Cancer Center at Magee-Womens Hospital
		Clinical Trials Office - UPMC Cancer Center at Magee-Womens Hospital	Ph:  412-647-2811
South Carolina
	Charleston
	Hollings Cancer Center at Medical University of South Carolina
		Clinical Trials Office - Hollings Cancer Center at Medical University of South Carolina	Ph:  843-792-9321
South Dakota
	Sioux Falls
	Avera Cancer Institute
		Samir Abu-Ghazaleh, MD	Ph:  605-331-3898
	Sanford Cancer Center at Sanford USD Medical Center
		Clinical Trials Office - Sanford Cancer Center	Ph:  605-328-1367
Tennessee
	Memphis
	Baptist Centers for Cancer Care
		Clinical Trials Office - Baptist Centers for Cancer Care	Ph:  901-226-3077
Texas
	Dallas
	Parkland Memorial Hospital
		David Miller, MD	Ph:  214-648-3026
	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
		Clinical Trials Office - Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Ph:  866-460-4673; 214-648-7097
	UT Southwestern University Hospital - Zale Lipshy
		David Miller, MD	Ph:  214-648-3026
	Houston
	M. D. Anderson Cancer Center at University of Texas
		Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas	Ph:  713-792-3245
	Temple
	CCOP - Scott and White Hospital
		Charles Capen, MD	Ph:  254-724-2576
Utah
	Salt Lake City
	LDS Hospital
		Ross Morgan, MD	Ph:  801-408-5757
		Ross Morgan, MD	Ph:  801-408-5757
Virginia
	Charlottesville
	University of Virginia Cancer Center
		Susan Modesitt	Ph:  434-924-9333 800-223-9173
	Roanoke
	Carilion Gynecologic Oncology Associates
		Dennis Scribner, MD	Ph:  540-345-8574
Wisconsin
	La Crosse
	Gundersen Lutheran Center for Cancer and Blood
		Clinical Trials Office - Gundersen Lutheran Cancer Center	Ph:  608-775-2385
			Email: cancerctr@gundluth.org
	Madison
	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
		Clinical Trials Office - University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Ph:  608-262-5223
	Waukesha
	Waukesha Memorial Hospital Regional Cancer Center
		Clinical Trials Office - Waukesha Memorial Hospital Regional Cancer Center	Ph:  262-928-7632

Registry Information
Official Title		Intraoperative Lymphatic Mapping in Patients With Stage I and II Squamous Carcinoma of the Vulva
Trial Start Date		1999-12-16
Trial Completion Date		2001-11-15 (estimated)
Registered in ClinicalTrials.gov		NCT00003325
Date Submitted to PDQ		1998-05-06
Information Last Verified		2009-01-05
NCI Grant/Contract Number		CA27469

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