radiation or observation only in endometrial cancer who have undergone surgery

Conditions: Endometrial Cancer

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.

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.

Eligibility 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

Keywords: stage i endometrial carcinoma stage ii endometrial carcinoma endometrial adenocarcinoma endometrial adenosquamous cell carcinoma endometrial papillary carcinoma endometrial clear cell carcinoma