Laparoscopic Surgery or Standard Surgery in Treating Patients With Endometrial Cancer or Cancer of the Uterus - Full Text View

Sponsor:	Gynecologic Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002706

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	Intervention	Phase
Endometrial Cancer Sarcoma	Procedure: conventional surgery Procedure: laparoscopic surgery	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Hysterectomy Soft Tissue Sarcoma Surgery Uterine Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Compare laparoscopy vs laparotomy surgical staging & results by conversion from laparoscopy to laparotomy [ Designated as safety issue: No ]
Compare laparoscopy vs laparotomy surgical staging & results by length of operative time [ Designated as safety issue: No ]
Compare laparoscopy vs laparotomy surgical staging & results by length of hospital stay [ Designated as safety issue: No ]
Compare laparoscopy vs laparotomy surgical staging & results by transfusions [ Designated as safety issue: No ]
Compare laparoscopy vs laparotomy surgical staging & results by deaths in 6 weeks [ Designated as safety issue: No ]
Compare laparoscopy vs laparotomy surgical staging & results by readmission [ Designated as safety issue: No ]
Compare laparoscopy vs laparotomy surgical staging & results by reoperations [ Designated as safety issue: No ]
Compare laparoscopy vs laparotomy surgical staging & results by complications during operation and for 6 weeks after surgery [ Designated as safety issue: No ]
Compare laparoscopy vs laparotomy for pathologic staging by nodes obtained from right and left pelvic and right and left para-aortic nodes [ Designated as safety issue: No ]
Compare laparoscopy vs laparotomy for pathologic staging by pelvic washing for cytology node counts [ Designated as safety issue: No ]
Compare laparoscopy vs laparotomy for pathologic staging by node positivity rates [ Designated as safety issue: No ]
Compare laparoscopy vs laparotomy for pathologic staging by surgical stage after surgery [ Designated as safety issue: No ]
Pattern of recurrence as assessed by the location of the first site of recurrence after 5 years [ Designated as safety issue: No ]
Progression-free survival every 3 months for 2 years and every 6 months for 5 years [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of life as assessed by FACT-G, body image, sexual function, SF-36, BPI, personal appearance, and return to work before surgery, at 1, 6 weeks, and 1 year [ Designated as safety issue: No ]

Estimated Enrollment:	2550
Study Start Date:	April 1996

Detailed Description:

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 older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002706

Hide Study Locations

Locations

United States, Arkansas
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Doctors Medical Center
Modesto, California, United States, 95350
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
Women's Cancer Center - Tarzana
Tarzana, California, United States, 91356
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307
Washington Cancer Institute at Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, Illinois
Evanston Northwestern Health Care - Evanston Hospital
Evanston, Illinois, United States, 60201
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States, 60521
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
St. Vincent Hospitals and Health Care Centers
Indianapolis, Indiana, United States, 46260
United States, Kentucky
Cancer Care at Our Lady of Bellefonte Hospital
Ashland, Kentucky, United States, 41101
United States, Maryland
Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
United States, Massachusetts
UMASS Memorial Cancer Center - University Campus
Worcester, Massachusetts, United States, 01655
United States, Michigan
Hurley Medical Center
Flint, Michigan, United States, 48502
United States, Minnesota
Fairview University Medical Center - University Campus
Minneapolis, Minnesota, United States, 55455
United States, Missouri
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65802
United States, Nevada
Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89109
Women's Cancer Center - Las Vegas
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
Overlook Hospital
Summit, New Jersey, United States, 07902
UMDNJ University Hospital
Newark, New Jersey, United States, 07103
United States, New Mexico
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States, 87106
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States, 10032
Long Island Cancer Center at Stony Brook University Hospital
Stony Brook, New York, United States, 11794
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
New York Oncology Hematology, P.C. at Capital District Hematology Oncology Associates, P.C. - Albany
Albany, New York, United States, 12208
Winthrop University Hospital
Mineola, New York, United States, 11501
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
North Shore University Hospital
Manhasset, New York, United States, 11030
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
Cleveland, Ohio, United States, 44106
Lake/University Ireland Cancer Center
Mentor, Ohio, United States, 44060
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States, 44307
St. Rita's Medical Center
Lima, Ohio, United States, 45801
United States, Oklahoma
Cancer Care Associates - Midtown Tulsa
Tulsa, Oklahoma, United States, 74104
Oklahoma University Medical Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Rhode Island
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
United States, South Dakota
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States, 57117-5134
United States, Tennessee
University of Tennessee College of Medicine
Memphis, Tennessee, United States, 38103
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030
Simmons Cancer Center at University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
United States, Vermont
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States, 05401
United States, Virginia
Carilion Gynecologic Oncology Associates
Roanoke, Virginia, United States, 24014
United States, Wisconsin
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Canada, Quebec
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, Canada, G1R 2J6

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Joan L. Walker, MD

Oklahoma University Cancer Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Walker JL, Piedmonte MR, Spirtos NM, Eisenkop SM, Schlaerth JB, Mannel RS, Spiegel G, Barakat R, Pearl ML, Sharma SK. Laparoscopy Compared With Laparotomy for Comprehensive Surgical Staging of Uterine Cancer: Gynecologic Oncology Group Study LAP2. J Clin Oncol. 2009 Oct 5; [Epub ahead of print]

Walker JL, Piedmonte M, Spirtos N, et al.: Surgical staging of uterine cancer: randomized phase III trial of laparoscopy vs laparotomy--A Gynecologic Oncology Group study (GOG): preliminary results. [Abstract] J Clin Oncol 24 (Suppl 18): A-5010, 2006.

Walker J, Piedmonte M, Spirtos N, et al.: Phase III trial of laparoscopy (scope) vs laparotomy (open) for surgical resection and comprehensive surgical staging of uterine cancer: a Gynecologic Oncology Group (GOG) study funded by NCI. [Abstract] Society of Gynecologic Oncologists, 2006 Annual Meeting on Women's Cancer, March 22-26, 2006, Palm Springs, CA. A-22, 2006.

Study ID Numbers:	CDR0000064513, GOG-LAP2
Study First Received:	November 1, 1999
Last Updated:	October 10, 2009
ClinicalTrials.gov Identifier:	NCT00002706 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I endometrial carcinoma
stage II endometrial carcinoma
endometrial adenocarcinoma
stage I uterine sarcoma
stage II uterine sarcoma

Additional relevant MeSH terms:

Genital Diseases, Female
Neoplasms, Connective and Soft Tissue
Neoplasms
Endometrial Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site

Genital Neoplasms, Female
Sarcoma
Uterine Diseases
Uterine Neoplasms
Urogenital Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009