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	Treatment or Intervention	Phase
stage I endometrial cancer stage II endometrial cancer endometrial adenocarcinoma endometrial adenosquamous cell carcinoma endometrial papillary carcinoma endometrial clear cell carcinoma	Procedure: adjuvant therapy  Procedure: brachytherapy  Procedure: conventional surgery  Procedure: laparoscopic surgery  Procedure: radiation therapy  Procedure: surgery	Phase III

Further Study Details: 

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.

Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven adenocarcinoma or adenosquamous cell carcinoma of the endometrium
• Intermediate-risk of recurrence after laparoscopically-assisted vaginal hysterectomy (with or without laparoscopic staging) or total abdominal hysterectomy and bilateral salpingo-oophorectomy
• Postoperative pathologic stage IA/IB (grade 3), stage IC (grade 1-3), or stage IIA (all grades)
• 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
• Patients whose sole criterion for increased risk is positive peritoneal cytology are not eligible
• No pathologically involved lymph nodes if staging procedure performed
• Stage I papillary serous or clear cell endometrial cancer allowed

PATIENT CHARACTERISTICS: Age:

• Not specified

Performance status:

• ECOG 0-3

Life expectancy:

• At least 3 years

Hematopoietic:

• WBC at least 2,000/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 10 g/dL

Hepatic:

• Not specified

Renal:

• Creatinine less than 2 times upper limit of normal
• No serious renal disease that would preclude radiotherapy

Cardiovascular:

• No serious cardiovascular disease that would preclude radiotherapy

Other:

• No history of inflammatory bowel disease such as ulcerative colitis
• No other malignancy within past 5 years except curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, colon cancer, or thyroid cancer
• No psychiatric or addictive disorder that would preclude study participation

PRIOR CONCURRENT THERAPY: Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• No prior anticancer hormonal therapy
• No concurrent progestogens

Radiotherapy:

• No prior pelvic irradiation
• No prior or other concurrent vaginal intracavitary radiotherapy

Surgery:

• See Disease Characteristics

Other:

• No prior anticancer therapy
• No other concurrent anticancer therapy

Minnesota
      St. Mary's - Duluth Clinic Cancer Center, Duluth,  Minnesota,  55805,  United States; Recruiting
Australia, Victoria
      Royal Women's Hospital, Carlton,  Victoria,  3053,  Australia; Recruiting
Canada, Alberta
      Cross Cancer Institute, Edmonton,  Alberta,  T6G 1Z2,  Canada; Recruiting
      Tom Baker Cancer Centre - Calgary, Calgary,  Alberta,  T2N 4N2,  Canada; Recruiting
Canada, British Columbia
      British Columbia Cancer Agency, Vancouver,  British Columbia,  V5Z 4E6,  Canada; Recruiting
      Fraser Valley Cancer Centre at Surrey Memorial Hospital, Surrey,  British Columbia,  V3V 1Z2,  Canada; Recruiting
Canada, New Brunswick
      Doctor Leon Richard Oncology Centre, Moncton,  New Brunswick,  E1C 8X3,  Canada; Recruiting
      Saint John Regional Hospital, Saint John,  New Brunswick,  E2L 4L2,  Canada; Recruiting
Canada, Newfoundland and Labrador
      Newfoundland Cancer Treatment and Research Foundation, St. Johns,  Newfoundland and Labrador,  A1B 3V6,  Canada; Recruiting
Canada, Nova Scotia
      Nova Scotia Cancer Centre at Queen Elizabeth II Health Sciences Centre, Halifax,  Nova Scotia,  B3H 1V7,  Canada; Recruiting
Canada, Ontario
      Cancer Care Ontario - Windsor Regional Cancer Centre, Windsor,  Ontario,  N8W 2X3,  Canada; Recruiting
      Cancer Care Ontario-London Regional Cancer Centre, London,  Ontario,  N6A 4L6,  Canada; Recruiting
      Cancer Centre of Southeastern Ontario, Kingston,  Ontario,  K7L 5P9,  Canada; Recruiting
      Humber River Regional Hospital - Weston, Weston,  Ontario,  M9N 1N8,  Canada; Recruiting
      Margaret and Charles Juravinski Cancer Centre, Hamilton,  Ontario,  L8V 5C2,  Canada; Recruiting
      Northeastern Ontario Regional Cancer Centre, Sudbury,  Ontario,  P3E 5J1,  Canada; Recruiting
      Princess Margaret Hospital, Toronto,  Ontario,  M5G 2M9,  Canada; Recruiting
      Regional Cancer Care at Thunder Bay Regional Health Sciences Centre, Thunder Bay,  Ontario,  P7B 6V4,  Canada; Recruiting
Canada, Quebec
      Centre Hospitalier de l'Universite de Montreal, Montreal,  Quebec,  H2L-4M1,  Canada; Recruiting
      Centre Hospitalier Universitaire de Quebec, Quebec City,  Quebec,  G1R 2J6,  Canada; Recruiting
      CHUS-Hopital Fleurimont, Sherbrooke,  Quebec,  J1H 5N4,  Canada; Recruiting
      Hopital Charles Lemoyne, Greenfield Park,  Quebec,  J4V 2H1,  Canada; Recruiting
      McGill Cancer Centre, Montreal,  Quebec,  H2W 1S6,  Canada; Recruiting
Canada, Saskatchewan
      Allan Blair Cancer Centre at Pasqua Hospital, Regina,  Saskatchewan,  S4T 7T1,  Canada; Recruiting
      Saskatoon Cancer Centre, Saskatoon,  Saskatchewan,  S7N 4H4,  Canada; Recruiting

Study chairs or principal investigators

Himu R. Lukka, MD,  Study Chair,  Margaret and Charles Juravinski Cancer Centre   
Timothy Joseph Whelan, MD,  Margaret and Charles Juravinski Cancer Centre   

Study ID Numbers:  CDR0000064915; CAN-NCIC-EN5; NCI-V96-0945; NCT00002807
Record last reviewed:  September 2004
Last Updated:  April 4, 2005
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002807
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08