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临床试验/NCT01709487
NCT01709487已完成1 期

Feasibility Study of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Patients With Stage III or Only Pleural Stage IV Ovarian Carcinoma in First Line Therapy

Jules Bordet Institute2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2010年5月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
19
试验地点
2
主要终点
mortality rate

研究概览

简要总结

First line treatment for advanced ovarian carcinoma hyperthermic intraperitoneal chemotherapy (HIPEC) after optimal debulking.

详细描述

Addition of HIPEC to the standard first line treatment of ovarian carcinoma.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •stage III or only pleural stage IV ovarian carcinoma first line treatment

排除标准

  • •incomplete surgery poor performance status bad general condition

研究组 & 干预措施

HIPEC surgery with chemotherapy

Experimental
  • 3 courses of pre-operative chemotherapy: carboplatin AUC = 5 IV + paclitaxel 175 mg/m2 IV every 3 weeks
  • Debulking surgery
  • HIPEC with cisplatin 50 mg/m2 intraperitoneally at the end of surgery
  • 3 courses of post-operative chemotherapy: carboplatin AUC = 5 IV + paclitaxel 175 mg/m2 IV every 3 weeks

干预措施: HIPEC (Procedure)

结局指标

主要结局

mortality rate

时间窗: 24 weeks

We will record the mortality rate of our interventions: 3 cycles of pre-operative chemotherapy, surgery and HIPEC, 3 cycles of post-operative chemotherapy.

次要结局

  • Overall survival(3 years)
  • progression free survival(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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