Radiation Therapy or Observation Only in Treating Patients With Endometrial Cancer Who Have Undergone Surgery
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase III Randomized Trial Comparing TAH BSO Versus TAH BSO Plus Adjuvant Pelvic Irradiation in Intermediate Risk Carcinoma of the Endometrium|
- Survival (combined with the ASTEC trial) [ Time Frame: 2009 ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: 2009 ] [ Designated as safety issue: No ]
|Study Start Date:||July 1996|
|Study Completion Date:||December 2009|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
|No Intervention: Observation|
Post-operative pelvic radiation therapy (45 Gy in 25 fractions over 5 weeks)
Radiation: radiation therapy
45 Gy in 25 fractions over 5 weeks
- 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.
|United States, Minnesota|
|St. Mary's - Duluth Clinic Cancer Center|
|Duluth, Minnesota, United States, 55805|
|Royal Women's Hospital|
|Carlton, Victoria, Australia, 3053|
|Tom Baker Cancer Centre - Calgary|
|Calgary, Alberta, Canada, T2N 4N2|
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|Fraser Valley Cancer Centre at British Columbia Cancer Agency|
|Surrey, British Columbia, Canada, V3V 1Z2|
|British Columbia Cancer Agency - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Canada, New Brunswick|
|Doctor Leon Richard Oncology Centre|
|Moncton, New Brunswick, Canada, E1C 8X3|
|Saint John Regional Hospital|
|Saint John, New Brunswick, Canada, E2L 4L2|
|Canada, Newfoundland and Labrador|
|Newfoundland Cancer Treatment and Research Foundation|
|St. Johns, Newfoundland and Labrador, Canada, A1B 3V6|
|Canada, Nova Scotia|
|Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre|
|Halifax, Nova Scotia, Canada, B3H 1V7|
|Margaret and Charles Juravinski Cancer Centre|
|Hamilton, Ontario, Canada, L8V 5C2|
|Cancer Centre of Southeastern Ontario|
|Kingston, Ontario, Canada, K7L 5P9|
|London Regional Cancer Program at London Health Sciences Centre|
|London, Ontario, Canada, N6A 4L6|
|Northeastern Ontario Regional Cancer Centre|
|Sudbury, Ontario, Canada, P3E 5J1|
|Regional Cancer Care at Thunder Bay Regional Health Sciences Centre|
|Thunder Bay, Ontario, Canada, P7B 6V4|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Humber River Regional Hospital - Weston|
|Weston, Ontario, Canada, M9N 1N8|
|Cancer Care Ontario - Windsor Regional Cancer Centre|
|Windsor, Ontario, Canada, N8W 2X3|
|Fleurimont, Quebec, Canada, J1H 5N4|
|Hopital Charles Lemoyne|
|Greenfield Park, Quebec, Canada, J4V 2H1|
|Centre Hospitalier de l'Universite de Montreal|
|Montreal, Quebec, Canada, H2L-4M1|
|McGill Cancer Centre at McGill University|
|Montreal, Quebec, Canada, H2W 1S6|
|Centre Hospitalier Universitaire de Quebec|
|Quebec City, Quebec, Canada, G1R 2J6|
|Allan Blair Cancer Centre at Pasqua Hospital|
|Regina, Saskatchewan, Canada, S4T 7T1|
|Saskatoon Cancer Centre|
|Saskatoon, Saskatchewan, Canada, S7N 4H4|
|Study Chair:||Himu R. Lukka, MD||Margaret and Charles Juravinski Cancer Centre|
|Study Chair:||Timothy J. Whelan, MD||Margaret and Charles Juravinski Cancer Centre|