A Phase III Randomized Trial Comparing TAH BSO Versus TAH BSO Plus Adjuvant Pelvic Irradiation in Intermediate Risk Carcinoma of the Endometrium
N/A
N/A
Female
Endometrial Cancer
Trial Information
A Phase III Randomized Trial Comparing TAH BSO Versus TAH BSO Plus Adjuvant Pelvic Irradiation in Intermediate Risk Carcinoma of the Endometrium
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.
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:
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Survival (combined with the ASTEC trial)
Outcome Time Frame:
2009
Safety Issue:
No
Principal Investigator
Himu R. Lukka, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Margaret and Charles Juravinski Cancer Centre
Authority:
Canada: Health Canada
Study ID:
EN5
NCT ID:
NCT00002807
Start Date:
July 1996
Completion Date:
December 2009
Related Keywords:
- Endometrial Cancer
- stage I endometrial carcinoma
- stage II endometrial carcinoma
- endometrial adenocarcinoma
- endometrial adenosquamous cell carcinoma
- endometrial papillary carcinoma
- endometrial clear cell carcinoma
- Endometrial Neoplasms
- Sarcoma, Endometrial Stromal
- Adenoma
Name | Location |
|---|---|
| St. Mary's - Duluth Clinic Cancer Center | Duluth, Minnesota 55805 |
