Phase I/II study of intensity-modulated radiation therapy as trimodality therapy for malignant pleural mesothelioma.
Phase 1
- Conditions
- Malignant Pleural Mesothelioma
- Registration Number
- JPRN-UMIN000002217
- Lead Sponsor
- Department of Radiation Oncology and Image-Applied Therapy, Kyoto University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 13
Inclusion Criteria
Not provided
Exclusion Criteria
1.Patients with any previous thoracic surgery not intend to complete resection or chemotherapy except for CDDP/pemetrexed. 2.Patients with no adequate reconstoration of diaphragma. 3.Active another neoplasm or previous (wihin 5 years) malignansies 4.Previous radiotherapy to the chest 5.Serious heart disease, arrhythmia, hypofunction of residual lung, uncontrolled infection, pyschological difficulty 6.Uncontrolled diabetes, any complications need steroids therapies. 7.Not suitable for participating in the study for any reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase I: Adverse events within 180 days after IMRT. Phase II: Relapse-free survival
- Secondary Outcome Measures
Name Time Method treatment(radiation therapy) completion rate, pattern of recurrence, overall survival