NCT01218490暂停3 期
Pelvic and Aortic-cava Lymphadenectomy Randomized Phase III for Advanced Ovarian Cancer
Institut Cancerologie de l'Ouest36 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2008年12月9日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 发起方
- 入组人数
- 450
- 试验地点
- 36
- 主要终点
- survival with out recurrence
研究概览
简要总结
It is a multicenter randomized trial of superior cleaning compared the absence of dissection in stage III patients with optimal surgical resection without retroperitoneal lymph node palpable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Age> 18 years
- •Karnofsky> 80, or ASA I-II
- •Primary ovarian adenocarcinoma, or primitive peritoneal
- •No retroperitoneal lymph node> 2cm (CT; MRI)
- •Complete surgical staging
- •Stage III-IV FIGO classification
- •Indication of systemic chemotherapy before surgery or post surgery
排除标准
- •Non Invasive Cancer
- •non-epithelial or borderline cancer
- •Pregnancy
- •Previous pelvic lymphadenectomy or aortic-cava for a disease other than ovarian cancer
- •Contraindication to Platinum and Paclitaxel
- •Borderline Ovarian Tumor
- •tumor recurrence
- •Incomplete surgery, resectable lesion, Surgery sub optimal (R> 1cm)
研究组 & 干预措施
lymphadenectomy
Experimental
after surgery of the ovarian cancer, patient will have Pelvis and aortic-cava lymphadenectomy
干预措施: ovarian cancer surgery (Procedure)
no lymphadectomy
No Intervention
after surgery, the patient will not have pelvic and aortic-cave lymphadenectomy
结局指标
主要结局
survival with out recurrence
时间窗: 5 years
次要结局
未报告次要终点
研究者
研究点 (36)
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