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

Alternate Title

Fibrin Sealant in Decreasing Lymphedema Following Surgery to Remove Lymph Nodes in Patients With Cancer of the Vulva

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Supportive care Active Over 18 NCI GOG-0195 NCI-P01-0201

Special Category: NIH Clinical Center trial

Objectives

1. Compare the incidence of lymphedema of the lower extremity after lymph node dissection in patients with vulvar malignancies treated with fibrin sealant vs standard care.
2. Compare the frequency of surgical complications in patients treated with fibrin sealant vs standard care.

Entry Criteria

Disease Characteristics:

• Diagnosis of vulvar malignancy
  • Stage I-IVB



• Planned radical vulvectomy or hemivulvectomy

  AND




• Ipsilateral or bilateral inguinal lymphadenectomy



• Presence of groin node metastases is allowed



• No primary or secondary lymphedema of the lower extremities

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for a prior malignancy
• Concurrent adjuvant chemotherapy allowed

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy for a prior malignancy
• No prior radiotherapy to pelvis, abdomen, inguinal area, or lower extremity

Surgery:

• See Disease Characteristics
• No prior inguinal surgery
• No prior surgery to veins or arteries of either leg
• No other concurrent elective surgery during same operative event as inguinal lymphadenectomy

Other:

• At least 30 days since prior investigational products or devices
• At least 7 days since prior anticoagulants
• Concurrent enrollment on GOG-0173 or other adjuvant treatment protocols is allowed
• No other concurrent investigational products or devices

Patient Characteristics:

Age:

• Over 18

Performance status:

• GOG 0-3

Life expectancy:

• Not specified

Hematopoietic:

• Platelet count at least 100,000/mm³
• Absolute neutrophil count at least 1,500/mm³
• No bleeding disorder

Hepatic:

• Bilirubin no greater than 1.5 times normal
• SGOT no greater than 3 times normal
• Albumin at least 3.0 g/dL

Renal:

• Creatinine no greater than 2.0 mg/dL

Cardiovascular:

• No prior lower extremity deep vein thrombosis

Other:

• No known sensitivity or anaphylaxis to bovine-derived products
• No known prior exposure to fibrin tissue adhesive
• No other malignancy within the past 5 years except nonmelanoma skin cancer
• No nonhealing ulcer or chronic infection of the lower extremity, including superficial phlebitis
• No prior fracture of any portion of either leg
• Preoperative circumferential measurements of legs must differ by less than 3 cm
• Not pregnant or nursing
• Fertile patients must use effective contraception

Projected Accrual

A total of 120-130 patients (60-65 per treatment arm) will be accrued for this study within 2 years.

Outline

This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

• Arm I: After radical vulvectomy or hemivulvectomy and lymphadenectomy, patients receive fibrin sealant to surgical site.



• Arm II: After surgery, patients receive standard care for closure of surgical site.

Lymphedema is assessed at time of drain removal, at week 6, and then at months 3 and 6.

Patients are followed at week 6 and at months 3 and 6.

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

Jay Carlson, DO, MC, LTC, Protocol chair		Ph: 202-782-6201 Email: jay.carlson@na.amedd.army.mil

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 Angeles
	Jonsson Comprehensive Cancer Center, UCLA
		Jonathan Berek, MD	Ph:  310-206-5161
	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
District of Columbia
	Washington
	Walter Reed Army Medical Center
		G. Scott Rose, MD	Ph:  202-782-8515
			Email: scott.rose@na.amedd.army.mil
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
	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
		Patient Recruitment	Ph:  1-888-NCI-1937
Michigan
	Ann Arbor
	CCOP - Michigan Cancer Research Consortium
		Philip Stella, MD	Ph:  877-590-5995
			Email: beekmanl@trinity-health.org
	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
	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
	Stony Brook
	Long Island Cancer Center at Stony Brook University Hospital
		Michael Pearl, MD	Ph:  631-444-2774 800-UMC-2215
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
	Columbus
	Arthur G. James Cancer Hospital at Ohio State University
		Jeffrey Fowler, MD	Ph:  614-293-8737 800-293-5066
Oklahoma
	Oklahoma City
	Oklahoma University Medical Center
		Joan Walker, MD	Ph:  405-271-8707
	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
	Philadelphia
	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
	Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
		Marta Crispens, MD	Ph:  615-322-2114 800-811-8480
			Email: marta.crispens@vanderbilt.edu
Texas
	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
Washington
	Tacoma
	Multicare Medical Center
		Roger Lee, MD	Ph:  253-403-1029
			Email: rogerblee@aol.com

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