NCT04257786Unknown不适用
Primary Cyto-reductive Surgery Vs Neo-adjuvant Chemotherapy (NAC) Followed by Surgery in Patients With Advanced Primary Epithelial Ovarian Cancer: A Pilot Randomized Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Percentage of patient where complete resection of the tumor can be achieved
研究概览
简要总结
Assessment of efficacy of primary cyto-reductive surgery in patients with advanced primary epithelial ovarian cancer in Comparison to patients receiving neo-adjuvant chemotherapy (NAC) followed by surgery in complete excision of the tumor reaching R0 without significant morbidity.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients diagnosed with epithelial ovarian cancer (By histopathology)
- •Age ≥ 18 years old
- •Advanced defined as (stage 2D or more ) by surgical staging.
- •Performance status (PS) according to Eastern Cooperative Oncology Group (ECOG) ≤ 2
- •Chemotherapy naïve
- •Informed consent
排除标准
- •Patients previously received chemotherapy or radiotherapy to any part of the abdomen or pelvis.
- •Patients with uncontrolled infection.
- •Patients with active bleeding or conditions associated with high risk of bleeding.
- •contraindications for surgery
- •contraindications To chemotherapy - bevacizumab
结局指标
主要结局
Percentage of patient where complete resection of the tumor can be achieved
时间窗: 3 month postoperative
complete resection of the tumor
次要结局
未报告次要终点
研究者
Ali hussien ali sayed
Specialist
Assiut University
研究点 (2)
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