NCT05876130招募中不适用
Postoperative Hypofractionated Intensity-modulated Radiotherapy Endometrial Cancer: A Prospective Phase II Trial (POHIM_EM Trial)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- 5-year disease-free survival rate
研究概览
简要总结
To investigate the non-inferiority of disease-free survival in women who received hypofractionated intensity-modulated whole pelvic radiation therapy (2.5 Gy x 16 fractions) after curative surgery for stage III endometrial cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed endometrioid type endometrial cancer
- •completion of hysterectomy and surgical staging
- •pathologically confirmed FIGO stage III
- •ECOG performance status 0 or 1
- •adjuvant chemotherapy was done or planned
排除标准
- •presence of distant metastasis
- •previous history of pelvic radiotherapy
- •severe and unstable medical condition
- •previous history of other carcinoma except for thyroid cancer, skin cancer, and endometrial cancer
结局指标
主要结局
5-year disease-free survival rate
时间窗: 5 years
disease-free survival rate after the time of surgery
次要结局
- acute toxicities(3 months)
- late toxicities(5 years)
研究者
Won Park
Professor
Samsung Medical Center
研究点 (2)
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