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

Alternate Title

Laparoscopic Surgery or Standard Surgery in Treating Patients With Endometrial Cancer or Cancer of the Uterus

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active 18 and over NCI GOG-LAP2

Special Category: NIH Clinical Center trial

Objectives

1. Compare the incidence of surgical complications, peri-operative morbidity, and mortality in patients with stage I or IIa, grade I-III endometrial cancer or uterine cancer undergoing surgical staging through laparoscopic assisted vaginal hysterectomy vs total abdominal hysterectomy.
2. Compare the length of hospital stay after surgery in patients receiving these treatments.
3. Compare the quality of life of patients receiving these treatments.
4. Compare the incidence and location of disease recurrence in patients receiving these treatments.

Entry Criteria

Disease Characteristics:

• Diagnosis of stage I or IIA, grade I-III endometrial adenocarcinoma or uterine sarcoma



• Must be considered a candidate for surgery



• No contraindication to laparoscopy



• No clinical or chest x-ray evidence of metastasis beyond the uterine corpus or macroscopic involvement of the endocervix

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior pelvic or abdominal radiotherapy

Surgery:

• See Disease Characteristics
• No prior retroperitoneal surgery

Patient Characteristics:

Age:

• 18 and over

Performance status:

• GOG 0-3

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm³
• Platelet count at least 100,000/mm³

Hepatic:

• Bilirubin no greater than 1.5 times normal
• SGOT no greater than 3 times normal

Renal:

• Creatinine no greater than 2.0 mg/dL

Other:

• Prior malignancy allowed if no current evidence of disease
• Not pregnant

Projected Accrual

A total of 2,550 patients will be accrued for this study within at least 10 years.

Outline

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

• Arm I: Patients undergo vaginal hysterectomy and bilateral salpingo- oophorectomy (BSO) via laparoscopy.



• Arm II: Patients undergo total abdominal hysterectomy and BSO via conventional laparotomy.

Patients in both arms also undergo pelvic and para-aortic lymph node sampling. Quality of life is assessed at baseline, at 1, 3, and 6 weeks, and then at 6 months.

Patients are followed at 6 weeks, every 3 months for 2 years, and then every 6 months for 3 years.

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

Joan Walker, MD, Protocol chair		Ph: 405-271-8707

U.S.A.
Arizona
	Phoenix
	CCOP - Western Regional, Arizona
		David King, MD, FACP	Ph:  602-239-2413
			Email: david.king@baannerhealth.com
California
	Los Angeles
	USC/Norris Comprehensive Cancer Center and Hospital
		John B. Schlaerth, MD	Ph:  323-865-3000 800-872-2273
	Los Gatos
	Women's Cancer Center at Community Hospital of Los Gatos
		Nick Spirtos, MD	Ph:  408-866-3843
			Email: nspirtos@wccenter.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
Hawaii
	Honolulu
	MBCCOP - Hawaii
		Brian Issell, MD	Ph:  808-586-3015
			Email: brian@crch.hawaii.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
Maryland
	Bethesda
	Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
		Patient Recruitment	Ph:  1-888-NCI-1937
Massachusetts
	Boston
	Tufts - New England Medical Center
		Kenneth Noller, MD	Ph:  617-636-2382
	Worcester
	University of Massachusetts Memorial Medical Center - University Campus
		Susan Zweizig, MD	Ph:  508-334-1160
			Email: zweizig@ummhc.org
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
Missouri
	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 York
	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
Ohio
	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
	Danville
	CCOP - Geisinger Clinic and Medical Center
		Nava Siegelmann-Danieli, MD	Ph:  570-271-6834
			Email: nsdanieli@geisinger.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
	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
	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
Wisconsin
	Madison
	University of Wisconsin Comprehensive Cancer Center
		Ellen Hartenbach, MD	Ph:  608-263-1209 800-622-8922
	Marshfield
	CCOP - Marshfield Clinic Research Foundation
		Anthony Evans, MD, PhD	Ph:  715-387-5161
			Email: evans.anthony@marshfieldclinic.org
Norway
	Oslo
	Norwegian Radium Hospital
		Gunnar Kristensen, MD, PhD	Ph:  47-22-934-000
			Email: gunnar.kristensen@klinmed.uio.no

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