Spots Global Cancer Trial Database for Radiation or Observation Only in Endometrial Cancer Who Have Undergone Surgery
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Trial Identification
Brief Title: Radiation or Observation Only in Endometrial Cancer Who Have Undergone Surgery
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 ID: NCT00002807
Conditions
Interventions
Study Description
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.
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
St. Mary's - Duluth Clinic Cancer Center, Duluth, Minnesota, United States
Royal Women's Hospital, Carlton, Victoria, Australia
Tom Baker Cancer Centre - Calgary, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
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
Saint John Regional Hospital, Saint John, New Brunswick, Canada
Newfoundland Cancer Treatment and Research Foundation, St. Johns, Newfoundland and Labrador, Canada
Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada
Margaret and Charles Juravinski Cancer Centre, Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario, Kingston, Ontario, Canada
London Regional Cancer Program at London Health Sciences Centre, London, Ontario, Canada
Northeastern Ontario Regional Cancer Centre, Sudbury, Ontario, Canada
Regional Cancer Care at Thunder Bay Regional Health Sciences Centre, Thunder Bay, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Humber River Regional Hospital - Weston, Weston, Ontario, Canada
Cancer Care Ontario - Windsor Regional Cancer Centre, Windsor, Ontario, Canada
CHUS-Hopital Fleurimont, Fleurimont, Quebec, Canada
Hopital Charles Lemoyne, Greenfield Park, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada
McGill Cancer Centre at McGill University, Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec, Quebec City, Quebec, Canada
Allan Blair Cancer Centre at Pasqua Hospital, Regina, Saskatchewan, Canada
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada
Contact Details
Name: Himu R. Lukka, MD
Affiliation: Margaret and Charles Juravinski Cancer Centre
Role: STUDY_CHAIR
Name: Timothy J. Whelan, MD
Affiliation: Margaret and Charles Juravinski Cancer Centre
Role: STUDY_CHAIR
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