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临床试验/NCT02467426
NCT02467426已完成不适用

Isolated Thoracic Perfusion With Hemofiltration (ITP-F) for Pretreated and Progressive Malignant Pleural Mesothelioma

Medias Klinikum for Surgical Oncology0 个研究点目标入组 23 人开始时间: 2009年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
23
主要终点
Survival

研究概览

简要总结

This is an observational study of isolated thoracic perfusion with subsequent hemofiltration to lower the concentration of the cytotoxic drugs as a locoregional therapeutic strategy in malignant pleural mesothelioma.

详细描述

Treatment of patients with progressive malignant pleural mesothelioma (MPM) after multimodal therapy is a therapeutic challenge. Survival of the patients is low and the treatment options are sparse. This is an observational study of isolated thoracic perfusion with subsequent hemofiltration as a locoregional therapeutic strategy in this situation.

23 pts. with epithelioid MPM were included in this phase II study after informed consent. All patients had progressive disease after multiple therapies and were recommended BSC of a MDT. Following insertion of a venous and arterial 21 ch. stop flow catheter via a femoral access, the inferior vena cava was blocked beneath the right atrium, the arterial catheter was blocked in the aorta at the diaphragm. The upper arms were blocked by pneumatic cuffs. Chemotherapy was given via the arterial catheter. Chemotherapy consisted of 60mg/m2 cisplatinum and 15mg/m2 mitoxantrone q for 3 weeks until progress. After administration of chemotherapy, thoracic perfusion with blocked stop-flow catheters was maintained for 15 minutes. After de-blocking of the catheters, hemofiltration was performed for 45 min. with 5l filtrate. The endpoint of the study was overall survival.Secondary endpoint was toxicity.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • History of pre-treated Malignant Pleural Mesothelioma, Progress after Staging

排除标准

  • Drug abuse, distant metastases, no bone marrow function

研究组 & 干预措施

Chemotherapy

intraarterial chemotherapy with cisplatin and mitoxantrone

干预措施: Chemotherapy (Drug)

结局指标

主要结局

Survival

时间窗: one year survival

Kaplan-Maier Plot

次要结局

  • Toxicity(4 weeks after therapy)

研究者

发起方
Medias Klinikum for Surgical Oncology
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Andreas Sendler

Senior Consultant, Dept. of Surgical Oncology

Medias Klinikum for Surgical Oncology

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