NCT03772028招募中3 期
Phase III Randomized Clinical Trial for Stage III Epithelial Ovarian Cancer Randomizing Between Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 538
- 试验地点
- 28
- 主要终点
- overall survival
研究概览
简要总结
stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy
详细描述
The objective of this study is to prove that treatment with primary cytoreductive surgery in combination with HIPEC (treatment arm) improves outcome compared to primary cytoreductive surgery without HIPEC (standard arm) with acceptable morbidity, in patients with FIGO stage III epithelial ovarian cancer who are eligible for primary cytoreductive surgery with no residual disease, or residual disease up to 2.5 mm.
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
- •candidate for primary CRS
- •histological or cytological proven FIGO stage III primary epithelial ovarian, fallopian tube, or extra-ovarian cancer
排除标准
- •history of previous malignancies within 5 years prior to inclusion
- •FIGO stage IV disease
- •complete primary cytoreduction is impossible
- •prior treatment for the current malignancy
研究组 & 干预措施
HIPEC
Experimental
Primary cytoreductive surgery with HIPEC with cisplatin
干预措施: cisplatin (Drug)
结局指标
主要结局
overall survival
时间窗: 1 year after last patient last visit
次要结局
- recurrence-free survival(1 year after last patient last visit)
- adverse events(30 days after end of treatment)
- cost evaluation(1 year after lplv)
研究者
研究点 (28)
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