NCT00715286Unknown3 期
Neoadjuvant Chemotherapy (NACT) Followed by Interval Debulking Surgery vs Upfront Surgery Followed by Chemotherapy (CT) in Advanced Epithelial Ovarian Carcinoma (EOC): A Prospective Randomized Study
All India Institute of Medical Sciences, New Delhi2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2001年11月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- to compare the optimal debulking rate in primary surgery group and neoadjuvant chemotherapy group
研究概览
简要总结
To determine the impact of Neoadjuvant chemotherapy on surgical debulking rate, overall and disease-free survival and quality of life (QOL) in patients with advanced EOC.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age:20 to 65 years
- •Epithelial ovarian carcinoma
- •Stage IIIc & IV (pleural effusion only)
- •ECOG PS 0-2
- •Cytology/biopsy positive patients
- •Good compliance
- •Previously untreated patients
排除标准
- •Any medical contraindication of surgery
- •Psychiatric illness
- •Cardiac, liver or renal dysfunction
结局指标
主要结局
to compare the optimal debulking rate in primary surgery group and neoadjuvant chemotherapy group
时间窗: post surgery
次要结局
- post operative morbidity(3 weeks post op)
研究者
研究点 (2)
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