Know Cancer

or
forgot password

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
N/A
Not Enrolling
Female
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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Joan L. Walker, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Oklahoma University Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000064513

NCT ID:

NCT00002706

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Hurley Medical CenterFlint, Michigan  48503
Hinsdale Hematology Oncology AssociatesHinsdale, Illinois  60521
St. Rita's Medical CenterLima, Ohio  45801
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Providence Saint Joseph Medical Center - BurbankBurbank, California  91505
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
University of Miami Sylvester Comprehensive Cancer CenterMiami, Florida  33136
UMASS Memorial Cancer Center - University CampusWorcester, Massachusetts  01605-2982
Long Island Cancer Center at Stony Brook University HospitalStony Brook, New York  11790-7775
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbus, Ohio  43210-1240
North Shore University HospitalManhasset, New York  11030
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
University of New Mexico Cancer Research and Treatment CenterAlbuquerque, New Mexico  87131
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97201-3098
Overlook HospitalSummit, New Jersey  07902-0220
Doctors Medical CenterModesto, California  95350
Women's Cancer Center - TarzanaTarzana, California  91356
Washington Cancer Institute at Washington Hospital CenterWashington, District of Columbia  20010
Evanston Northwestern Health Care - Evanston HospitalEvanston, Illinois  60201
St. Vincent Hospitals and Health Care CentersIndianapolis, Indiana  46260
Cancer Care at Our Lady of Bellefonte HospitalAshland, Kentucky  41101
Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital CenterBaltimore, Maryland  21237
Fairview University Medical Center - University CampusMinneapolis, Minnesota  55455
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Nevada Cancer Research FoundationLas Vegas, Nevada  89109
Women's Cancer Center - Las VegasLas Vegas, Nevada  89102
Carol G. Simon Cancer Center at Morristown Memorial HospitalMorristown, New Jersey  07962
UMDNJ University HospitalNewark, New Jersey  07103
New York Oncology Hematology, P.C. at Capital District Hematology Oncology Associates, P.C. - AlbanyAlbany, New York  12208
SUNY Downstate Medical CenterBrooklyn, New York  11203
Winthrop University HospitalMineola, New York  11501
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve UniversityCleveland, Ohio  44106
Lake/University Ireland Cancer CenterMentor, Ohio  44060
Oklahoma University Medical CenterOklahoma City, Oklahoma  73104
Cancer Care Associates - Midtown TulsaTulsa, Oklahoma  74104
Women and Infants Hospital of Rhode IslandProvidence, Rhode Island  02905
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
University of Tennessee College of MedicineMemphis, Tennessee  38103
Simmons Cancer Center at University of Texas Southwestern Medical Center at DallasDallas, Texas  75390
M.D. Anderson Cancer Center at University of TexasHouston, Texas  77030
Carilion Gynecologic Oncology AssociatesRoanoke, Virginia  24014