NCT04956601尚未招募不适用
A Multicenter, Randomized, Controlled Trial of Adjuvant Radiotherapy in Patients With Early Endometrial Cancer Based on Moderate Risk Molecules Classification
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- DFS
研究概览
简要总结
To compare the effect of vaginal brachytherapy as adjuvant treatment after operation when compared to pelvic external beam radiotherapy in patients with early endometrial cancer based on moderate risk molecules classification.
详细描述
After being informed the study and potential risk，all patients giving written informed consent will be undergo a 1-week screening period determine eligibility for study entry. At week 0, patients who meet the eligibility will be randomized in a 1:1 ratio to vaginal brachytherapy or pelvic external beam radiotherapy. After treatment, patients were followed up regularly.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Endometrial adenocarcinoma is confirmed by pathology, and the molecular types were microsatellite instability type and low copy type;
- •Stage IA and grade 3 or stage IB (FIGO 2009), without substantial lymph-vascular space invasion;
- •Surgery must have included a hysterectomy and bilateral adnexectomy. Pelvic lymph node sampling and para-aortic lymph node sampling are optional;
- •ECOG score is 0-2;
- •The interval time between surgery and radiotherapy is no more than 8 weeks;
- •The routine blood examination was normal;
- •Compliance is good and informed consent is voluntarily signed.
排除标准
- •The patients receive chemotherapy;
- •History of previous malignant disease;
- •Previous diagnosis of Crohn's disease or ulcerative colitis.
结局指标
主要结局
DFS
时间窗: 5-year
disease-free survival from being received treatment
次要结局
- Failure mode(5-year)
- OS(5-year)
- Toxicities(5-year)
研究者
Junjie Wang
Peking University Third Hospital
Peking University Third Hospital
研究点 (1)
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