Radiation Therapy or Observation Only in Treating Patients With Endometrial Cancer Who Have Undergone Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00002807|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : November 28, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Cancer||Radiation: radiation therapy||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||116 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Randomized Trial Comparing TAH BSO Versus TAH BSO Plus Adjuvant Pelvic Irradiation in Intermediate Risk Carcinoma of the Endometrium|
|Study Start Date :||July 1996|
|Actual Primary Completion Date :||March 2007|
|Actual Study Completion Date :||December 2009|
|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
- Survival (combined with the ASTEC trial) [ Time Frame: 2009 ]
- Progression-free survival [ Time Frame: 2009 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002807
|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|