Spots Global Cancer Trial Database for Surgery Plus Medroxyprogesterone in Preventing Endometrial Cancer
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Trial Identification
Brief Title: Surgery Plus Medroxyprogesterone in Preventing Endometrial Cancer
Official Title: 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
Study ID: NCT00003179
Conditions
Interventions
Study Description
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.
Detailed Description: OBJECTIVES: * Determine the joint occurrence of atypical hyperplasia and adenocarcinoma in patients diagnosed at initial biopsy to have complex atypical hyperplasia. * Compare the histologic response rates in patients with atypical endometrial hyperplasia treated with oral medroxyprogesterone acetate (Provera) vs intramuscular medroxyprogesterone acetate suspension (Depo-Provera) . OUTLINE: This is a randomized, two-part study. * Part A: Patients undergo immediate hysterectomy. * Part B: Patients are randomized to 1 of 2 arms. * Arm I: Patients receive oral medroxyprogesterone acetate (Provera) once daily for 3 months. * Arm II: Patients receive medroxyprogesterone acetate suspension (Depo- Provera) intramuscularly once monthly for 3 months (days 1, 31, and 62). Patients undergo hysterectomy at the end of the third month. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A minimum of 360 patients for part A and 140 patients (70 per arm) for part B will be accrued for this study.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Arizona Cancer Center, Tucson, Arizona, United States
Community Hospital of Los Gatos, Los Gatos, California, United States
Chao Family Comprehensive Cancer Center, Orange, California, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
Albert B. Chandler Medical Center, University of Kentucky, Lexington, Kentucky, United States
Marlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Keesler Medical Center - Keesler AFB, Keesler AFB, Mississippi, United States
Ellis Fischel Cancer Center - Columbia, Columbia, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Cooper Hospital/University Medical Center, Camden, New Jersey, United States
State University of New York Health Sciences Center - Stony Brook, Stony Brook, New York, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina, United States
Barrett Cancer Center, Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States
University of Oklahoma College of Medicine, Oklahoma City, Oklahoma, United States
Abington Memorial Hospital, Abington, Pennsylvania, United States
Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Brookview Research, Inc., Nashville, Tennessee, United States
University of Texas Medical Branch, Galveston, Texas, United States
Fletcher Allen Health Care - Medical Center Campus, Burlington, Vermont, United States
Cancer Center at the University of Virginia, Charlottesville, Virginia, United States
Norwegian Radium Hospital, Oslo, , Norway
Contact Details
Name: John P. Curtin, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: STUDY_CHAIR
Name: George L. Mutter, MD
Affiliation: Dana-Farber/Brigham and Women's Cancer Center
Role:
Name: Francisco A. R. Garcia, MD, MPH
Affiliation: University of Arizona
Role:
Name: Richard Zaino, MD
Affiliation: Milton S. Hershey Medical Center
Role:
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