Dose escalation study of intensity-modulated radiotherapy (IMRT) for ipsilateral intrathoracic recurrence after pneumonectomy (lung cancer/mediastinal tumor) or mesothelioma after extrapleural pneumonectomy
Phase 1
- Conditions
- Recurrence of thoracic malignancy (lung cancer/mediastinal tumor), or mesothelioma
- Registration Number
- JPRN-UMIN000004066
- Lead Sponsor
- Department of Radiation Oncology, Gunma University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 9
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patient with severe or uncontrolled systemic disease? 2) Patient with systemic active infection 3) Patient who is in pregnancy, lactating, or with a possibility of the pregnancy 4) Patient who is diagnosed with interstitial pneumonia or lung fibrosis by chest CT 5) Patient with severe heart disease (e.g. heart failure requiring medication, myocardial infarction/unstable angina pectoris within the past 3 months, uncontrolled arrhythmia) 6) Patient who is judged inappropriate for the entry into the study by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of adverse events, protocol compliance rate, to estimate the maximum tolerating dose (MTD) and to determine the recommended dose (RD)
- Secondary Outcome Measures
Name Time Method Median local control and estimation of chest pain