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A Phase III Randomized Clinical Trial of Laparoscopic Pelvic and Para-Aortic Node Sampling With Vaginal Hysterectomy and BSO Versus Open Laparotomy With Pelvic and Para-Aortic Node Sampling and Abdominal Hysterectomy and BSO in Endometrial Adenocarcinoma, Clinical Stage I, IIA, Grade I, II, III

Phase 3
18 Years
Not Enrolling
Endometrial Cancer, Sarcoma

Thank you

Trial Information

A Phase III Randomized Clinical Trial of Laparoscopic Pelvic and Para-Aortic Node Sampling With Vaginal Hysterectomy and BSO Versus Open Laparotomy With Pelvic and Para-Aortic Node Sampling and Abdominal Hysterectomy and BSO in Endometrial Adenocarcinoma, Clinical Stage I, IIA, Grade I, II, III


- 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

- Compare the quality of life of patients receiving these treatments.

- Compare the incidence and location of disease recurrence in patients receiving these

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

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

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

Inclusion Criteria


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

- 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



- 18 and over

Performance status:

- GOG 0-3

Life expectancy:

- Not specified


- WBC at least 3,000/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 1.5 times normal

- SGOT no greater than 3 times normal


- Creatinine no greater than 2.0 mg/dL


- Prior malignancy allowed if no current evidence of disease

- Not pregnant


Biologic therapy:

- Not specified


- Not specified

Endocrine therapy:

- Not specified


- No prior pelvic or abdominal radiotherapy


- See Disease Characteristics

- No prior retroperitoneal surgery

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Compare laparoscopy vs laparotomy surgical staging & results by conversion from laparoscopy to laparotomy

Safety Issue:


Principal Investigator

Joan L. Walker, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Oklahoma University Cancer Institute


United States: Federal Government

Study ID:




Start Date:

April 1996

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • Sarcoma
  • stage I endometrial carcinoma
  • stage II endometrial carcinoma
  • endometrial adenocarcinoma
  • stage I uterine sarcoma
  • stage II uterine sarcoma
  • Adenocarcinoma
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Uterine Neoplasms
  • Adenoma
  • Sarcoma



Memorial Sloan-Kettering Cancer Center New York, New York  10021
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
Hurley Medical Center Flint, Michigan  48503
Hinsdale Hematology Oncology Associates Hinsdale, Illinois  60521
St. Rita's Medical Center Lima, Ohio  45801
Medical College of Wisconsin Cancer Center Milwaukee, Wisconsin  53226
Providence Saint Joseph Medical Center - Burbank Burbank, California  91505
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
University of Miami Sylvester Comprehensive Cancer Center Miami, Florida  33136
UMASS Memorial Cancer Center - University Campus Worcester, Massachusetts  01605-2982
Long Island Cancer Center at Stony Brook University Hospital Stony Brook, New York  11790-7775
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Columbus, Ohio  43210-1240
North Shore University Hospital Manhasset, New York  11030
Brooke Army Medical Center Fort Sam Houston, Texas  78234-6200
University of New Mexico Cancer Research and Treatment Center Albuquerque, New Mexico  87131
Fletcher Allen Health Care - University Health Center Campus Burlington, Vermont  05401
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Herbert Irving Comprehensive Cancer Center at Columbia University New York, New York  10032
Cancer Institute at Oregon Health and Science University Portland, Oregon  97201-3098
Overlook Hospital Summit, New Jersey  07902-0220
Doctors Medical Center Modesto, California  95350
Women's Cancer Center - Tarzana Tarzana, California  91356
Washington Cancer Institute at Washington Hospital Center Washington, District of Columbia  20010
Evanston Northwestern Health Care - Evanston Hospital Evanston, Illinois  60201
St. Vincent Hospitals and Health Care Centers Indianapolis, Indiana  46260
Cancer Care at Our Lady of Bellefonte Hospital Ashland, Kentucky  41101
Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center Baltimore, Maryland  21237
Fairview University Medical Center - University Campus Minneapolis, Minnesota  55455
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
St. John's Regional Health Center Springfield, Missouri  65804
Nevada Cancer Research Foundation Las Vegas, Nevada  89109
Women's Cancer Center - Las Vegas Las Vegas, Nevada  89102
Carol G. Simon Cancer Center at Morristown Memorial Hospital Morristown, New Jersey  07962
UMDNJ University Hospital Newark, New Jersey  07103
New York Oncology Hematology, P.C. at Capital District Hematology Oncology Associates, P.C. - Albany Albany, New York  12208
SUNY Downstate Medical Center Brooklyn, New York  11203
Winthrop University Hospital Mineola, New York  11501
McDowell Cancer Center at Akron General Medical Center Akron, Ohio  44307
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University Cleveland, Ohio  44106
Lake/University Ireland Cancer Center Mentor, Ohio  44060
Oklahoma University Medical Center Oklahoma City, Oklahoma  73104
Cancer Care Associates - Midtown Tulsa Tulsa, Oklahoma  74104
Women and Infants Hospital of Rhode Island Providence, Rhode Island  02905
Sioux Valley Hospital and University of South Dakota Medical Center Sioux Falls, South Dakota  57117-5134
University of Tennessee College of Medicine Memphis, Tennessee  38103
Simmons Cancer Center at University of Texas Southwestern Medical Center at Dallas Dallas, Texas  75390
M.D. Anderson Cancer Center at University of Texas Houston, Texas  77030
Carilion Gynecologic Oncology Associates Roanoke, Virginia  24014