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Sponsored by: |
NCIC Clinical Trials Group |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002807 |
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 | Intervention | Phase |
---|---|---|
Endometrial Cancer |
Procedure: adjuvant therapy Procedure: conventional surgery Procedure: laparoscopic surgery Radiation: brachytherapy Radiation: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Phase III Randomized Trial Comparing TAH BSO Versus TAH BSO Plus Adjuvant Pelvic Irradiation in Intermediate Risk Carcinoma of the Endometrium |
Estimated Enrollment: | 400 |
Study Start Date: | July 1996 |
OBJECTIVES:
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.
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.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven adenocarcinoma or adenosquamous cell carcinoma of the endometrium
Patients with more than 50% myometrial invasion (grade 1 or 2) or less than 50% myometrial invasion (grade 3) but with positive peritoneal cytology also eligible
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Minnesota | |
St. Mary's - Duluth Clinic Cancer Center | |
Duluth, Minnesota, United States, 55805 | |
Australia, Victoria | |
Royal Women's Hospital | |
Carlton, Victoria, Australia, 3053 | |
Canada, Alberta | |
Cross Cancer Institute | |
Edmonton, Alberta, Canada, T6G 1Z2 | |
Tom Baker Cancer Centre - Calgary | |
Calgary, Alberta, Canada, T2N 4N2 | |
Canada, British Columbia | |
British Columbia Cancer Agency - Vancouver Cancer Centre | |
Vancouver, British Columbia, Canada, V5Z 4E6 | |
Fraser Valley Cancer Centre at British Columbia Cancer Agency | |
Surrey, British Columbia, Canada, V3V 1Z2 | |
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 | |
Canada, Ontario | |
Cancer Care Ontario - Windsor Regional Cancer Centre | |
Windsor, Ontario, Canada, N8W 2X3 | |
Cancer Centre of Southeastern Ontario | |
Kingston, Ontario, Canada, K7L 5P9 | |
Humber River Regional Hospital - Weston | |
Weston, Ontario, Canada, M9N 1N8 | |
London Regional Cancer Program at London Health Sciences Centre | |
London, Ontario, Canada, N6A 4L6 | |
Margaret and Charles Juravinski Cancer Centre | |
Hamilton, Ontario, Canada, L8V 5C2 | |
Northeastern Ontario Regional Cancer Centre | |
Sudbury, Ontario, Canada, P3E 5J1 | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 | |
Regional Cancer Care at Thunder Bay Regional Health Sciences Centre | |
Thunder Bay, Ontario, Canada, P7B 6V4 | |
Canada, Quebec | |
Centre Hospitalier de l'Universite de Montreal | |
Montreal, Quebec, Canada, H2L-4M1 | |
Centre Hospitalier Universitaire de Quebec | |
Quebec City, Quebec, Canada, G1R 2J6 | |
CHUS-Hopital Fleurimont | |
Fleurimont, Quebec, Canada, J1H 5N4 | |
Hopital Charles Lemoyne | |
Greenfield Park, Quebec, Canada, J4V 2H1 | |
McGill Cancer Centre at McGill University | |
Montreal, Quebec, Canada, H2W 1S6 | |
Canada, Saskatchewan | |
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 |
Investigator: | Timothy J. Whelan, MD | Margaret and Charles Juravinski Cancer Centre |
Study ID Numbers: | CDR0000064915, CAN-NCIC-EN5, NCI-V96-0945 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00002807 History of Changes |
Health Authority: | United States: Federal Government |
stage I endometrial carcinoma stage II endometrial carcinoma endometrial adenocarcinoma |
endometrial adenosquamous cell carcinoma endometrial papillary carcinoma endometrial clear cell carcinoma |
Genital Neoplasms, Female Adjuvants, Immunologic Uterine Diseases Urogenital Neoplasms Endometrial Cancer Carcinoma Genital Diseases, Female |
Endometrial Neoplasms Adenocarcinoma, Clear Cell Carcinoma, Papillary Uterine Neoplasms Adenocarcinoma Carcinoma, Adenosquamous |
Genital Diseases, Female Neoplasms Endometrial Neoplasms Neoplasms by Site |
Genital Neoplasms, Female Uterine Diseases Uterine Neoplasms Urogenital Neoplasms |