Clinical trial on Efficacy and Safety of the Next-generated intrapleural hyperthermic chemotherapy for thoracic malignancies with dissemination and malignant pleural effusions
- Conditions
- Thoracic malignancies with dissemination and carcinomatous pleuritis and malignant pleural effusions (unresected advanced lung cancer, postoperative intrathoracic recurrence, malignant pleural mesothelioma, intrathoracic metastasis due to breast and colon cancers, and the other malignant diseases)
- Registration Number
- JPRN-UMIN000015343
- Lead Sponsor
- niversity of Miyazaki Hospital Department of Surgery II
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
1)symptomatic brain metastasis 2)the complications (hemoptysis >= 2.5ml of fresh blood, arterial thromboembolism (brain infarction, temporarily ischemic attack, myocardial infarction, angina pectoris), venous thoromboembolism (deep vein thromboembolism, pulmonary embolism), uncontrollable hypertension, intestinal perforation, severe fistula, broncho-esophageal fistula, intraabdominal inflammation, congenital bleeding tendency, abnormality of blood coagulation, uncontrollable diabetic mellitus, infection, active intestinal pneuminitis 3)surgery within 28 days (except for lung cancer) 4)scheduled thoracic irradiation during bevasizumab treatment 5)symptomatic cardiac tamponade 6)needs to receive an emergency irradiation due to supra vena cava syndrome 7)active pneumonia and intestinal pneumonitis displayed by chest X-ray/chest computed-tomographic examination 8)difficult to enroll because of complication with psychosomatic disease or mental symptomati problems 9)Others. Patients judged for inappropriation by attending physician or lead principal investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Efficacy(response rate of local tumor) 2)Control rate of malignant pleural effusions 3)Pathological assessment 4)Cytology of drainaged pleural effusions 5)Monitoring of Intrathoracic temperature 6)Analysis of free-radical productives (oxidative stress and anti-oxidative capacity 7)Time to treatment failure (TTF) 8)Changes of quality of life 9)Chest Drain-free Survival 10)Sympton-related Progression-free survival 11)Changes of pulmonary function test
- Secondary Outcome Measures
Name Time Method 1)Safety, adverse event (NCI-CTCAE, ver 4.0) 2)intraoperative, postoperative complications (NCI-CTCAE ver 4.0) 3)Overall Survival 4)Progression-free survival 5)postoperative thoracic drainaged fluid amounts 6)postoperative thoracic drainaged duration 7)post-treatments