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
medroxyprogesterone
Enfermedades Urogenitales+7
+ Enfermedades Genitales
+ Enfermedades Urogenitales Femeninas y Complicaciones del Embarazo
Estudio de Prevención
Resumen
Fecha de inicio: 1 de noviembre de 1998
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 360 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Prevención
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Mujer
Sexo biológico de los participantes elegibles para inscribirse.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
DISEASE CHARACTERISTICS: Histologically confirmed atypical endometrial hyperplasia with recommended treatment with either: An immediate hysterectomy (Part A) OR A three-month delay prior to hysterectomy and a randomized choice of treatment with oral medroxyprogesterone acetate (Provera) or medroxyprogesterone acetate suspension (Depo-Provera) during the 3 months (Part B with arms I and II) Diagnosed by dilation and curettage, Novak curettage, Vabra aspirate or Pipelle endometrial biopsy No recognized endometrial carcinoma Must not be considered inoperable PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Granulocyte count at least 1,500/mm^3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal Renal: Creatinine no greater than 2 times normal Cardiovascular No prior thrombophlebitis or thromboembolic phenomena No prior cerebrovascular disorders Other: No prior or concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ of the uterine cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: See Disease Characteristics Radiotherapy: Not specified Surgery: See Disease Characteristics
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 31 ubicaciones
Community Hospital of Los Gatos
Los Gatos, United StatesChao Family Comprehensive Cancer Center
Orange, United StatesWalter Reed Army Medical Center
Washington D.C., United States