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Uterine Fibroids |
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Clinical Trial: Laparoscopic Surgery or Standard Surgery in Treating Patients With Endometrial Cancer or Cancer of the Uterus
This study is currently recruiting patients.
Purpose
RATIONALE: Laparoscopic surgery is a less invasive type of surgery for cancer of the uterus and may have fewer side effects and improve recovery. It is not known whether laparoscopic surgery is more effective than standard surgery in treating endometrial cancer.
PURPOSE: This randomized phase III trial is studying laparoscopic surgery to see how well it works compared to standard surgery in treating patients with endometrial cancer or cancer of the uterus.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| stage I endometrial cancer stage II endometrial cancer endometrial adenocarcinoma stage I uterine sarcoma stage II uterine sarcoma | Procedure: conventional surgery Procedure: laparoscopic surgery Procedure: surgery | Phase III |
MedlinePlus related topics: Soft Tissue Sarcoma; Uterine Cancer; Uterine Fibroids
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Vaginal Hysterectomy and Bilateral Salpingo-Oophorectomy (BSO) Via Laparoscopy Versus Total Abdominal Hysterectomy and BSO Via Conventional Laparotomy Plus Pelvic and Para-Aortic Lymph Node Sampling in Patients With Stage I or IIA, Grade I-III Endometrial Cancer or Uterine Cancer
Further Study Details:
OBJECTIVES:
- 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.
- Compare the length of hospital stay after surgery in patients receiving these treatments.
- Compare the quality of life of patients receiving these treatments.
- Compare the incidence and location of disease recurrence in patients receiving these treatments.
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.
PROJECTED ACCRUAL: A total of 2,550 patients will be accrued for this study within at least 10 years.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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
PATIENT CHARACTERISTICS: Age:
- 18 and over
Performance status:
- GOG 0-3
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Platelet count at least 100,000/mm^3
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
PRIOR CONCURRENT THERAPY: Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
Surgery:
- See Disease Characteristics
- No prior retroperitoneal surgery
Location and Contact Information
Arizona
CCOP - Western Regional, Arizona, Phoenix, Arizona, 85006-2726, United States; Recruiting
David Kyle King, MD, FACP 602-239-2413 david.king@baannerhealth.com
California
USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, 90033-0804, United States; Recruiting
John B. Schlaerth, MD 323-865-3000
Women's Cancer Center - Los Gatos, Los Gatos, California, 95032, United States; Recruiting
Nick M. Spirtos, MD 408-866-3843 nspirtos@wccenter.com
Delaware
CCOP - Christiana Care Health Services, Newark, Delaware, 19713, United States; Recruiting
Stephen Scott Grubbs, MD 302-623-4100
District of Columbia
Walter Reed Army Medical Center, Washington, District of Columbia, 20307-5001, United States; Recruiting
G. Scott Rose, MD 202-782-8515 scott.rose@na.amedd.army.mil
Hawaii
MBCCOP - Hawaii, Honolulu, Hawaii, 96813, United States; Recruiting
Brian F. Issell, MD 808-586-3015 brian@crch.hawaii.edu
Illinois
CCOP - Carle Cancer Center, Urbana, Illinois, 61801, United States; Recruiting
Kendrith M. Rowland, MD 217-383-4083 kendrith.rowland@carle.com
CCOP - Central Illinois, Decatur, Illinois, 62794-9640, United States; Recruiting
L. Stewart Massad, MD 217-545-8882
CCOP - Evanston, Evanston, Illinois, 60201, United States; Recruiting
Gershon Y. Locker, MD, FACP 847-570-2518 glocker@enh.org
MBCCOP - University of Illinois at Chicago, Chicago, Illinois, 60612, United States; Recruiting
Lawrence Eric Feldman, MD 312-335-3614
Hinsdale, Illinois, 60521, United States; Recruiting
Sudarshan K. Sharma, MD 630-856-6757 drsharma@ameritech.net
Indiana
Indiana University Cancer Center, Indianapolis, Indiana, 46202-5289, United States; Recruiting
Katherine Yvonne Look, MD 317-274-8987 klook@iupui.edu
Saint Joseph Regional Medical Center, South Bend, Indiana, 46617, United States; Recruiting
Michael W. Method, MD, MPH 574-237-8010 mmethod@mhopc.com
Massachusetts
Cancer Center at Tufts - New England Medical Center, Boston, Massachusetts, 02111, United States; Recruiting
Kenneth L. Noller, MD 617-636-2382
UMASS Memorial Cancer Center - University Campus, Worcester, Massachusetts, 01605-2982, United States; Recruiting
Susan L. Zweizig, MD 508-334-1160 zweizig@ummhc.org
Michigan
CCOP - Grand Rapids, Grand Rapids, Michigan, 49503, United States; Recruiting
Kathleen Jo Yost, MD 616-391-1230
CCOP - Kalamazoo, Kalamazoo, Michigan, 49007-3731, United States; Recruiting
Raymond Sterling Lord, MD 269-373-7488 rlord@wmcc.org
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, 48106, United States; Recruiting
Philip J. Stella, MD 734-712-5237 beekmanl@trinity-health.org
Minnesota
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, 55416, United States; Recruiting
Patrick J. Flynn, MD 952-993-1517 patrick.flynn@usoncology.com
Mayo Clinic Cancer Center, Rochester, Minnesota, 55905-0001, United States; Recruiting
Harry J. Long, MD 507-284-4320 long.harry@mayo.edu
University of Minnesota Cancer Center, Minneapolis, Minnesota, 55455, United States; Recruiting
Linda F. Carson, MD 612-626-3347 carso001@umn.edu
Missouri
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, 65807, United States; Recruiting
John Wendall Goodwin, MD 417-269-4520 jwg684@sprg.mercy.net
CCOP - Kansas City, Kansas City, Missouri, 64131, United States; Recruiting
William T. Stephenson, MD 816-823-0555
Nebraska
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska, 68106, United States; Recruiting
James A. Mailliard, MD 402-280-4364 jamailliard@mrcc.cc
New York
Long Island Cancer Center at Stony Brook University Hospital, Stony Brook, New York, 11790-7775, United States; Recruiting
Michael L. Pearl, MD 631-444-2774
Memorial Sloan-Kettering Cancer Center, New York, New York, 10021, United States; Recruiting
Carol L. Brown, MD 212-639-7659
North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, 27599-7570, United States; Recruiting
Wesley C. Fowler, MD 919-966-1196 wfowler@med.unc.edu
Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus, Ohio, 43210-1240, United States; Recruiting
Jeffrey McCabe Fowler, MD 614-293-8737
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, 44124, United States; Recruiting
Peter Graham Rose, MD 216-444-1712 rosep@ccf.org
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland, Ohio, 44106, United States; Recruiting
Steven E. Waggoner, MD 216-844-5011
Oklahoma
University of Oklahoma College of Medicine, Oklahoma City, Oklahoma, 73104, United States; Recruiting
Robert S. Mannel, MD 405-271-8787 robert-mannel@ouhsc.edu
Oregon
CCOP - Columbia River Oncology Program, Portland, Oregon, 97225, United States; Recruiting
Keith S. Lanier, MD 503-216-6260
Pennsylvania
CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania, 17822-2001, United States; Recruiting
Nava Siegelmann-Danieli, MD 570-271-6834 nsdanieli@geisinger.edu
UPMC Cancer Center at Magee-Womens Hospital, Pittsburgh, Pennsylvania, 15213-3180, United States; Recruiting
Joseph L. Kelley, MD 412-641-5418 jkelley@mail.magee.edu
Tennessee
Southeast Gynecologic Oncology Associates, Knoxville, Tennessee, 37917, United States; Recruiting
Kenneth F. Cofer, MD 865-673-9250
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville, Tennessee, 37232-2516, United States; Recruiting
Marta Ann Crispens, MD 615-322-2114 marta.crispens@vanderbilt.edu
Texas
CCOP - Scott and White Hospital, Temple, Texas, 76508, United States; Recruiting
Lucas Wong, MD 254-724-1053 lwong@swmail.sw.org
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas, Texas, 75390-9032, United States; Recruiting
David Scott Miller, MD 214-648-3026 david.miller@utsouthwestern.edu
University of Texas Medical Branch, Galveston, Texas, 77555-0587, United States; Recruiting
Edward V. Hannigan, MD 409-772-2368 ehanniga@utmb.edu
Vermont
Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus, Burlington, Vermont, 05401, United States; Recruiting
Cheung Wong, MD 802-847-5110 cheung.wong@vtmednet.org
Virginia
Cancer Center at the University of Virginia, Charlottesville, Virginia, 22908, United States; Recruiting
Willie Albert Andersen, MD 434-924-9333
Wisconsin
CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin, 54449, United States; Recruiting
Anthony Evans, MD, PhD 715-387-5161 evans.anthony@marshfieldclinic.org
University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, 53792-6188, United States; Recruiting
Ellen Hartenbach, MD 608-263-1209
Norway
Norwegian Radium Hospital, Oslo, N-0310, Norway; Recruiting
Gunnar B. Kristensen, MD, PhD 47-22-93-40-00 gunnar.kristensen@klinmed.uio.no
Study chairs or principal investigators
Joan L. Walker, MD, Study Chair, Oklahoma University Medical Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers: CDR0000064513; GOG-LAP2; NCT00002706
Record last reviewed: February 2005
Last Updated: March 10, 2005
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00002706
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: February 2005
Last Updated: March 10, 2005
Record first received: November 1, 1999
ClinicalTrials.gov Identifier: NCT00002706
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- ACOG's Physician Directory (American College of Obstetricians and Gynecologists)
- ClinicalTrials.gov: Leiomyoma (National Institutes of Health)
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