Surgery Plus Medroxyprogesterone in Preventing Endometrial Cancer
A Two-Part Study of the Treatment of Atypical Endometrial Hyperplasia: Part A: A Prospective Study of Immediate Hysterectomy; Part B: A Randomized Phase II Study of Medroxyprogesterone Acetate Versus Depoprovera
2 other identifiers
interventional
360
2 countries
31
Brief Summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of surgery with or without medroxyprogesterone may be an effective way to prevent the development of endometrial cancer in patients who have endometrial hyperplasia. PURPOSE: Phase II trial to compare the effectiveness of surgery alone with that of medroxyprogesterone followed by surgery in preventing endometrial cancer in patients who have endometrial hyperplasia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2006
CompletedJune 10, 2013
July 1, 2006
7.3 years
November 1, 1999
June 7, 2013
Conditions
Keywords
Interventions
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Gynecologic Oncology Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (31)
Arizona Cancer Center
Tucson, Arizona, 85724-5024, United States
Community Hospital of Los Gatos
Los Gatos, California, 95032, United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5001, United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289, United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505, United States
Keesler Medical Center - Keesler AFB
Keesler Air Force Base, Mississippi, 39534-2576, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Cooper Hospital/University Medical Center
Camden, New Jersey, 08103-1489, United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11794-8091, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, 27157-1065, United States
Barrett Cancer Center
Cincinnati, Ohio, 45267-0526, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240, United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001-3788, United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Medical University of South Carolina
Charleston, South Carolina, 29425-2233, United States
Brookview Research, Inc.
Nashville, Tennessee, 37203, United States
University of Texas Medical Branch
Galveston, Texas, 77555-0587, United States
Fletcher Allen Health Care - Medical Center Campus
Burlington, Vermont, 05401, United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908, United States
Norwegian Radium Hospital
Oslo, N-0310, Norway
Related Publications (2)
Bartels PH, Garcia FA, Trimble CL, Kauderer J, Curtin J, Lim PC, Hess LM, Silverberg S, Zaino RJ, Yozwiak M, Bartels HG, Alberts DS. Karyometry in atypical endometrial hyperplasia: a Gynecologic Oncology Group study. Gynecol Oncol. 2012 Apr;125(1):129-35. doi: 10.1016/j.ygyno.2011.12.422. Epub 2011 Dec 9.
PMID: 22155796RESULTTrimble CL, Kauderer J, Zaino R, Silverberg S, Lim PC, Burke JJ 2nd, Alberts D, Curtin J. Concurrent endometrial carcinoma in women with a biopsy diagnosis of atypical endometrial hyperplasia: a Gynecologic Oncology Group study. Cancer. 2006 Feb 15;106(4):812-9. doi: 10.1002/cncr.21650.
PMID: 16400639RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
John P. Curtin, MD
Memorial Sloan Kettering Cancer Center
George L. Mutter, MD
Dana-Farber/Brigham and Women's Cancer Center
Francisco A. R. Garcia, MD, MPH
University of Arizona
Richard Zaino, MD
Milton S. Hershey Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Sponsor Type
- NETWORK
Study Record Dates
First Submitted
November 1, 1999
First Posted
January 27, 2003
Study Start
November 1, 1998
Primary Completion
February 1, 2006
Last Updated
June 10, 2013
Record last verified: 2006-07