A phase II study of talc instillation for the patients with malignant pleural effusions - J-TALC

Hideo Saka, M.D., National Hospital Organization, Nagoya Medical Center0 个研究点目标入组 30 人开始时间: 2009年6月22日最近更新: 2023年10月17日

试验速览

Effective and safe

•1) Cytologically or histologically proven malignant pleural effusions
•2) Symptomatic with malignant pleural effusion and needs intervention
•3) Re-expansion of the lung by chest tube drainage
•4) Improved symptoms by drainage of pleural effusion
•5) Life expectancy of 30 days or more after pleurodesis
•6) Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2 after malignant pleural effusion drainage
•7) 20 years of age or more, and less than 75 years.
•8) Written informed consent from the patient

•1) Hypersensitive to talc
•2) Hypersensitive to lidocaine chloride
•3) Severe infection
•4) Severe pulmonary emphysema or fibrosis
•5) Treatment of active heart failure
•6) History of myocardial infarction within 30 days of entry
•7) Severe coagulopathy
•8) SpO2 less than 90% after drainage
•9) Severe pleural adhesion
•10) Indication for bilateral pleurodesis
•11) History of thoracic surgery like lung resection or pleuro-pulmonary resection on the affected side
•12) History of pleurodesis on the affected side
•13) Use of systemic corticosteroid and non-steroidal anti-inflammatory agents
•14) Pregnant or milk-feeding female, patient who hopes to bear child, or who could not keep contraceptive maneuver
•15) Participant of other trial drug study within 6 monthes
•16) Inappropriate to enter this trial judged by the physician in charge

发起方

Hideo Saka, M.D., National Hospital Organization, Nagoya Medical Center