Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Cancer of the Uterus
- Conditions
- Endometrial CancerSarcoma
- Registration Number
- NCT00002459
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 224
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (28)
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Tom Baker Cancer Center - Calgary
🇨🇦Calgary, Alberta, Canada
CHUS-Hopital Fleurimont
🇨🇦Fleurimont, Quebec, Canada
Centre Henri Becquerel
🇫🇷Rouen, France
Spedali Civili
🇮🇹Brescia, Italy
Istituto Scientifico H.S. Raffaele
🇮🇹Milano, Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori
🇮🇹Milan, Italy
Ospedale San Gerardo
🇮🇹Monza, Italy
Universita di Padova
🇮🇹Padova, Italy
I.R.C.C.S. Policlinico San Matteo
🇮🇹Pavia, Italy
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