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

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.

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:

• No prior pelvic or abdominal radiotherapy

Surgery:

• See Disease Characteristics
• No prior retroperitoneal surgery

Arizona
      CCOP - Western Regional, Arizona, Phoenix,  Arizona,  85006-2726,  United States; Recruiting
California
      USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles,  California,  90033-0804,  United States; Recruiting
      Women's Cancer Center - Los Gatos, Los Gatos,  California,  95032,  United States; Recruiting
Delaware
      CCOP - Christiana Care Health Services, Newark,  Delaware,  19713,  United States; Recruiting
District of Columbia
      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5001,  United States; Recruiting
Hawaii
      MBCCOP - Hawaii, Honolulu,  Hawaii,  96813,  United States; Recruiting
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States; Recruiting
      CCOP - Central Illinois, Decatur,  Illinois,  62794-9640,  United States; Recruiting
      CCOP - Evanston, Evanston,  Illinois,  60201,  United States; Recruiting
      MBCCOP - University of Illinois at Chicago, Chicago,  Illinois,  60612,  United States; Recruiting
      Hinsdale,  Illinois,  60521,  United States; Recruiting
Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5289,  United States; Recruiting
      Saint Joseph Regional Medical Center, South Bend,  Indiana,  46617,  United States; Recruiting
Massachusetts
      Cancer Center at Tufts - New England Medical Center, Boston,  Massachusetts,  02111,  United States; Recruiting
      UMASS Memorial Cancer Center - University Campus, Worcester,  Massachusetts,  01605-2982,  United States; Recruiting
Michigan
      CCOP - Grand Rapids, Grand Rapids,  Michigan,  49503,  United States; Recruiting
      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States; Recruiting
      CCOP - Michigan Cancer Research Consortium, Ann Arbor,  Michigan,  48106,  United States; Recruiting
Minnesota
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States; Recruiting
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905-0001,  United States; Recruiting
      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States; Recruiting
Missouri
      CCOP - Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States; Recruiting
      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States; Recruiting
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68106,  United States; Recruiting
New York
      Long Island Cancer Center at Stony Brook University Hospital, Stony Brook,  New York,  11790-7775,  United States; Recruiting
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting
North Carolina
      Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill,  North Carolina,  27599-7570,  United States; Recruiting
Ohio
      Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University, Columbus,  Ohio,  43210-1240,  United States; Recruiting
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44124,  United States; Recruiting
      Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland,  Ohio,  44106,  United States; Recruiting
Oklahoma
      University of Oklahoma College of Medicine, Oklahoma City,  Oklahoma,  73104,  United States; Recruiting
Oregon
      CCOP - Columbia River Oncology Program, Portland,  Oregon,  97225,  United States; Recruiting
Pennsylvania
      CCOP - Geisinger Clinic and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States; Recruiting
      UPMC Cancer Center at Magee-Womens Hospital, Pittsburgh,  Pennsylvania,  15213-3180,  United States; Recruiting
Tennessee
      Southeast Gynecologic Oncology Associates, Knoxville,  Tennessee,  37917,  United States; Recruiting
      Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center, Nashville,  Tennessee,  37232-2516,  United States; Recruiting
Texas
      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States; Recruiting
      Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas, Dallas,  Texas,  75390-9032,  United States; Recruiting
      University of Texas Medical Branch, Galveston,  Texas,  77555-0587,  United States; Recruiting
Vermont
      Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus, Burlington,  Vermont,  05401,  United States; Recruiting
Virginia
      Cancer Center at the University of Virginia, Charlottesville,  Virginia,  22908,  United States; Recruiting
Wisconsin
      CCOP - Marshfield Clinic Research Foundation, Marshfield,  Wisconsin,  54449,  United States; Recruiting
      University of Wisconsin Comprehensive Cancer Center, Madison,  Wisconsin,  53792-6188,  United States; Recruiting
Norway
      Norwegian Radium Hospital, Oslo,  N-0310,  Norway; Recruiting

Study chairs or principal investigators

Joan L. Walker, MD,  Study Chair,  Oklahoma University Medical Center   

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