NCT02324595已完成2 期
Minimally Invasive Interval Debulking Surgery in Ovarian Neoplasm: a Feasibility Study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Operative complication rate
研究概览
简要总结
Phase II multicentric study
详细描述
The aim of this prospective Phase II multicentric study is to assess feasibility and early complications rate of "total laparoscopic/robotic" interval debulking surgery in patients with a clinical complete/partial response to neoadjuvant chemotherapy for advanced ovarian 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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age >18 years,
- •Advanced ovarian cancer submitted to neoadjuvant chemotherapy,
- •Clinical or serological complete/partial response (RECIST; GCIG),
- •PS ≤ 2 (ECOG),
- •Informed consent
排除标准
- •Borderline and non-epithelial ovarian tumors,
- •Stable/progressive disease,
- •Severe cardiopulmonary disease,
- •BMI > 40
结局指标
主要结局
Operative complication rate
时间窗: 30 days
Intra- and post-operative complication rate of total laparoscopic/robotic interval debulking surgery
次要结局
- Overall Survival(One year)
- Progression Free survival(one year)
研究者
Prof. Giovanni Scambia
Director, Dip per la Tutela della Salute della Donna e della Vita Nascente, del Bambino e dell'Adolescente
Catholic University of the Sacred Heart
研究点 (4)
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