JPRN-UMIN000015343
Completed
Phase 2
Clinical trial on Efficacy and Safety of the Next-generated intrapleural hyperthermic chemotherapy for thoracic malignancies with dissemination and malignant pleural effusions - Phase II study of next-generated intrapleural hyperthermic chemotherapy for thoracic malignancies
niversity of Miyazaki Hospital Department of Surgery II0 sites30 target enrollmentOctober 5, 2014
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- 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)
- Sponsor
- niversity of Miyazaki Hospital Department of Surgery II
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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