Intrapleural hypotonic cisplatin treatment for malignant pleural effusion in non-small cell lung cancer patients with intestinal lung disease. A multicenter non randomized trial.
- Conditions
- Interstitial pneumonia merger stage IV non-small cell lung cancer case with the malignant pleural effusion
- Registration Number
- JPRN-UMIN000023102
- Lead Sponsor
- ational Hospital Organization Kinki -Chuo Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 35
Not provided
Exclusion criteria were as follows 1) All 1-3 were found within 30 days or possibility of acute exacerbation of intestinal lung disease. 1. worsening of respiratory distress 2. emerging ground grass attenuation or consolidation of the lung by computed tomography 3. worsening of PaO2 >= 10Torr 2) lung cancer had not been treated within 30 days 3) active double cancer 4) allergic reaction for lidocaine 5) carcinomatous pericarditis 6) uncontrolled heart failure 7) myocardial infarction within 30days 8) unstable angina pectoris 9) active infectious diseases 10) drug allery>= Grade3 11) Pregnancy, lactating woman, women of childbearing potential and patients not intend to prevent pregnancy 12) allergic pulmonary disorders or acute exacerbation of intestinal lung diseases 13) surgical treatment had previously been done for thorax in the malignant effusion 14) steroid usage (predonine >= 5mg) 15) SpO2 <90(under room air) 16) physician assessed that patients are not adequate for this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The pleural effusion control rate (30days after administration of hypotonic cisplatin for malignant pleural effusion)
- Secondary Outcome Measures
Name Time Method Proportion of acute exacerbation of intestinal lung disease,overall survival, pleural effusion free progression free survival, Toxicities