Trial Information

Phase III Randomized Study of Adjuvant Pelvic Radiotherapy Versus Observation Alone in Patients With Completely Resected, Stage I or II, High-Grade Uterine Sarcoma

OBJECTIVES: I. Compare the rates of pelvic recurrence and development of distant metastases
in patients with completely resected, stage I or II, high-grade uterine sarcoma treated with
adjuvant pelvic radiotherapy vs observation alone.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
center, tumor histology (leiomyosarcoma vs mixed mesodermal sarcoma vs endometrial stromal
sarcoma), and surgical procedure (total abdominal hysterectomy (TAH) with or without
bilateral salpingo-oophorectomy (BSO) vs TAH and BSO with pelvic and para-aortic node
sampling and random biopsies). Patients are randomized to 1 of 2 treatment arms. Arm I:
Beginning within 6 weeks after surgery, patients undergo pelvic radiotherapy 5 days a week
for 5.6 weeks. Arm II: Patients undergo observation alone. Patients are followed every 2
months for 1 year, every 3 months for 2 years, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 200 patients (100 per arm) will be accrued for this study
within 3 years.