A Phase III Randomized Trial Comparing TAH BSO Versus TAH BSO Plus Adjuvant Pelvic Irradiation in Intermediate Risk Carcinoma of the Endometrium
radiation therapy
Urogenital Diseases+9
+ Genital Diseases
+ Female Urogenital Diseases and Pregnancy Complications
Treatment Study
Summary
Study start date: July 4, 1996
Actual date on which the first participant was enrolled.OBJECTIVES: Compare the overall survival in patients with intermediate-risk endometrial cancer treated with pelvic radiotherapy vs observation after laparoscopically-assisted vaginal hysterectomy or total abdominal hysterectomy and bilateral salpingo-oophorectomy. Compare the time to locoregional recurrence (i.e., in the vaginal mucosa or elsewhere in the central pelvic area or lateral pelvic walls) in patients treated with these regimens. Compare the duration of ultimate pelvic control and event-free survival in patients treated with these regimens. Compare the toxic effects of these regimens in these patients. Compare the quality of life of patients treated with these regimens. Compare sexual health issues in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, tumor grade (1 vs 2 vs 3), surgical staging (yes vs no), and sexual health assessment (yes vs no). Patients undergo laparoscopic-assisted vaginal hysterectomy or total abdominal hysterectomy and bilateral salpingo-oophorectomy. After surgery, patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo observation alone. Arm II: Beginning within 12 weeks (preferably within 6-8 weeks) after surgery, patients undergo radiotherapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity. Protocol-defined brachytherapy is allowed. Quality of life is assessed at baseline; at 16-18 weeks after surgery (arm I) or 5 and 9 weeks after initiating radiotherapy (arm II); and then at 6, 12, 18, 24, 36, 48, and 60 months. Patients are followed every 3 months for 2 years, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.116 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Until 120 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically proven adenocarcinoma or adenosquamous cell carcinoma of the endometrium Intermediate-risk of recurrence after laparoscopically-assisted vaginal hysterectomy (with or without laparoscopic staging) or total abdominal hysterectomy and bilateral salpingo-oophorectomy Postoperative pathologic stage IA/IB (grade 3), stage IC (grade 1-3), or stage IIA (all grades) Patients with more than 50% myometrial invasion (grade 1 or 2) or less than 50% myometrial invasion (grade 3) but with positive peritoneal cytology also eligible Patients whose sole criterion for increased risk is positive peritoneal cytology are not eligible No pathologically involved lymph nodes if staging procedure performed Stage I papillary serous or clear cell endometrial cancer allowed PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-3 Life expectancy: At least 3 years Hematopoietic: WBC at least 2,000/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL Hepatic: Not specified Renal: Creatinine less than 2 times upper limit of normal No serious renal disease that would preclude radiotherapy Cardiovascular: No serious cardiovascular disease that would preclude radiotherapy Other: No history of inflammatory bowel disease such as ulcerative colitis No other malignancy within past 5 years except curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, colon cancer, or thyroid cancer No psychiatric or addictive disorder that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: No prior anticancer hormonal therapy No concurrent progestogens Radiotherapy: No prior pelvic irradiation No prior or other concurrent vaginal intracavitary radiotherapy Surgery: See Disease Characteristics Other: No prior anticancer therapy No other concurrent anticancer therapy
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
No InterventionGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 25 locations
St. Mary's - Duluth Clinic Cancer Center
Duluth, United StatesOpen St. Mary's - Duluth Clinic Cancer Center in Google MapsRoyal Women's Hospital
Carlton, AustraliaTom Baker Cancer Centre - Calgary
Calgary, CanadaCross Cancer Institute
Edmonton, Canada