Sarcoma Clinical Trial
Official title:
Phase III Randomized Study of Adjuvant Pelvic Radiotherapy Versus Observation Alone in Patients With Completely Resected, Stage I or II, High-Grade Uterine Sarcoma
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet
known whether receiving radiation therapy or no further therapy after surgery is more
effective for cancer of the uterus.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with
that of no further therapy in treating patients who have stage I or stage II cancer of the
uterus that has been surgically removed.
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.
;
Primary Purpose: Treatment
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