NCT01820858进行中（未招募）3 期
A Multicenter, Prospective, Randomized Trial of the Efficacy and Safety of the Postoperative Adjuvant Treatment in Patients With High-risk Stage I Endometrial Carcinoma
Ding Ma3 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2012年11月最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Disease-free survival (DFS)
研究概览
简要总结
This randomized trial is studying the efficacy and safety of the chemotherapy compared with radiation therapy alone as adjuvant treatment after operation in Patients with high risk and Stage I endometrial carcinoma.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •FIGO stage: Ⅰ, endometrial carcinoma;
- •Female, Chinese women;
- •Initial treatment is staging surgery;
- •Pathological diagnosis: Endometrial adenocarcinoma;
- •Pathologic examination and meet the following one of the indications of adjuvant therapy: ① histopathological grading in poorly differentiated: G3; ② ≥50% myometrial invasion; ③ vascular space involvement;
- •No prior treatment;
- •Provide written informed consent.
排除标准
- •Unable to receive surgery and/or unsuitable for radiotherapy or chemotherapy;
- •Family history of ovarian cancer;
- •Suffering from other malignancies;
- •Concurrently participating in other clinical trials;
- •Unable or unwilling to sign informed consents;
- •Unable or unwilling to abide by protocol.
研究组 & 干预措施
Adjuvant Chemotherapy
Experimental
Paclitaxel: 175 mg/m(2) intravenously (IV); followed by Paraplatin (Carboplatin Injection) AUC=5 IV. 3-6 cycles as necessary.
干预措施: Paclitaxel (Drug)
Adjuvant Chemotherapy
Experimental
Paclitaxel: 175 mg/m(2) intravenously (IV); followed by Paraplatin (Carboplatin Injection) AUC=5 IV. 3-6 cycles as necessary.
干预措施: Paraplatin (Carboplatin Injection) (Drug)
Adjuvant Radiotherapy
Active Comparator
- Histopathological grade G3 and <50% myometrial invasion: Vaginal brachytherapy 5Gy, 3 times;
- Histopathological grade G3 and vascular space involvement: Pelvic radiation 45-50 Gy;
- ≥50% myometrial invasion: Pelvic radiation 50 Gy + Vaginal brachytherapy 5Gy, 2-4 times.
干预措施: Pelvic Radiation (Radiation)
Adjuvant Radiotherapy
Active Comparator
- Histopathological grade G3 and <50% myometrial invasion: Vaginal brachytherapy 5Gy, 3 times;
- Histopathological grade G3 and vascular space involvement: Pelvic radiation 45-50 Gy;
- ≥50% myometrial invasion: Pelvic radiation 50 Gy + Vaginal brachytherapy 5Gy, 2-4 times.
干预措施: Vaginal Brachytherapy 1 (Radiation)
Adjuvant Radiotherapy
Active Comparator
- Histopathological grade G3 and <50% myometrial invasion: Vaginal brachytherapy 5Gy, 3 times;
- Histopathological grade G3 and vascular space involvement: Pelvic radiation 45-50 Gy;
- ≥50% myometrial invasion: Pelvic radiation 50 Gy + Vaginal brachytherapy 5Gy, 2-4 times.
干预措施: Vaginal brachytherapy 2 (Radiation)
结局指标
主要结局
Disease-free survival (DFS)
时间窗: 3-year DFS
次要结局
- Side effect of adjuvant chemotherapy(3-month，6-month，1-year and 3-year)
- Complications of radiotherapy(3-month，6-month，1-year and 3-year)
- Quality of Life(3-month，6-month，1-year and 3-year)
- Overall survival (OS)(3-year OS)
研究者
Ding Ma
Director of the department of Obstetrics and Gynecology, Tongji Hospital
Huazhong University of Science and Technology
研究点 (3)
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