NCT00002807已完成不适用
A Phase III Randomized Trial Comparing TAH BSO Versus TAH BSO Plus Adjuvant Pelvic Irradiation in Intermediate Risk Carcinoma of the Endometrium
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 25
- 主要终点
- Survival (combined with the ASTEC trial)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 120 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Observation
No Intervention
Radiation
Experimental
Post-operative pelvic radiation therapy (45 Gy in 25 fractions over 5 weeks)
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Survival (combined with the ASTEC trial)
时间窗: 2009
次要结局
- Progression-free survival(2009)
研究者
研究点 (25)
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