A Phase III Randomized Trial Comparing TAH BSO Versus TAH BSO Plus Adjuvant Pelvic Irradiation in Intermediate Risk Carcinoma of the Endometrium
- 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
- 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
- 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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Survival (combined with the ASTEC trial)
Himu R. Lukka, MD
Margaret and Charles Juravinski Cancer Centre
Canada: Health Canada
|St. Mary's - Duluth Clinic Cancer Center||Duluth, Minnesota 55805|