Radiation or Observation Only in Endometrial Cancer Who Have Undergone Surgery
- Conditions
- Endometrial Cancer
- Interventions
- Radiation: radiation therapy
- Registration Number
- NCT00002807
- Lead Sponsor
- NCIC Clinical Trials Group
- Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known whether radiation therapy is more effective than observation only after sugery in treating endometrial cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to observation only in treating patients with stage I or stage II endometrial cancer who have undergone hysterectomy and oophorectomy.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 116
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Radiation radiation therapy Post-operative pelvic radiation therapy (45 Gy in 25 fractions over 5 weeks)
- Primary Outcome Measures
Name Time Method Survival (combined with the ASTEC trial) 2009
- Secondary Outcome Measures
Name Time Method Progression-free survival 2009
Trial Locations
- Locations (25)
Tom Baker Cancer Centre - Calgary
🇨🇦Calgary, Alberta, Canada
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
Newfoundland Cancer Treatment and Research Foundation
🇨🇦St. Johns, Newfoundland and Labrador, Canada
Margaret and Charles Juravinski Cancer Centre
🇨🇦Hamilton, Ontario, Canada
Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada
London Regional Cancer Program at London Health Sciences Centre
🇨🇦London, Ontario, Canada
Regional Cancer Care at Thunder Bay Regional Health Sciences Centre
🇨🇦Thunder Bay, Ontario, Canada
Humber River Regional Hospital - Weston
🇨🇦Weston, Ontario, Canada
CHUS-Hopital Fleurimont
🇨🇦Fleurimont, Quebec, Canada
Cancer Care Ontario - Windsor Regional Cancer Centre
🇨🇦Windsor, Ontario, Canada
Hopital Charles Lemoyne
🇨🇦Greenfield Park, Quebec, Canada
McGill Cancer Centre at McGill University
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
🇨🇦Quebec City, Quebec, Canada
St. Mary's - Duluth Clinic Cancer Center
🇺🇸Duluth, Minnesota, United States
Saint John Regional Hospital
🇨🇦Saint John, New Brunswick, Canada
Cancer Centre of Southeastern Ontario
🇨🇦Kingston, Ontario, Canada
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Allan Blair Cancer Centre at Pasqua Hospital
🇨🇦Regina, Saskatchewan, Canada
Royal Women's Hospital
🇦🇺Carlton, Victoria, Australia
Fraser Valley Cancer Centre at British Columbia Cancer Agency
🇨🇦Surrey, British Columbia, Canada
British Columbia Cancer Agency - Vancouver Cancer Centre
🇨🇦Vancouver, British Columbia, Canada
Doctor Leon Richard Oncology Centre
🇨🇦Moncton, New Brunswick, Canada
Saskatoon Cancer Centre
🇨🇦Saskatoon, Saskatchewan, Canada
Northeastern Ontario Regional Cancer Centre
🇨🇦Sudbury, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal
🇨🇦Montreal, Quebec, Canada