Endometrial Cancer
Conditions
Keywords
stage I endometrial carcinoma, stage II endometrial carcinoma, endometrial adenocarcinoma, endometrial adenosquamous cell carcinoma, endometrial papillary carcinoma, endometrial clear cell carcinoma
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.
Interventions
RADIATIONradiation therapy
45 Gy in 25 fractions over 5 weeks
Sponsors
NCIC Clinical Trials Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 120 Years
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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival (combined with the ASTEC trial) | 2009 |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival | 2009 |
Countries
Australia, Canada, United States
Outcome results
None listed