NCT00002807CompletedNot Applicable
A Phase III Randomized Trial Comparing TAH BSO Versus TAH BSO Plus Adjuvant Pelvic Irradiation in Intermediate Risk Carcinoma of the Endometrium
NCIC Clinical Trials Group25 sites in 3 countries116 target enrollmentStarted: July 4, 1996Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- NCIC Clinical Trials Group
- Enrollment
- 116
- Locations
- 25
- Primary Endpoint
- Survival (combined with the ASTEC trial)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 120 Years (Child, Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion 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:
- •Not specified
- •Performance status:
- •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
- •Not specified
- •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
- •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
- •See Disease Characteristics
- •No prior anticancer therapy
- •No other concurrent anticancer therapy
Exclusion Criteria
- Not provided
Arms & Interventions
Observation
No Intervention
Radiation
Experimental
Post-operative pelvic radiation therapy (45 Gy in 25 fractions over 5 weeks)
Intervention: radiation therapy (Radiation)
Outcomes
Primary Outcomes
Survival (combined with the ASTEC trial)
Time Frame: 2009
Secondary Outcomes
- Progression-free survival(2009)
Investigators
Study Sites (25)
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