Recurrence of thoracic malignancy (lung cancer/mediastinal tumor), or mesothelioma
Conditions
Interventions
Sponsors
Department of Radiation Oncology, Gunma University Graduate School of Medicine
Hidaka Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Pathologically proven thoracic malignancy (lung cancer, mesothelioma or mediastinal tumor) 2) Ipsilateral thoracic/pleural recurrence of thoracic malignancy (lung cancer/mediastinal tumor) after pneumonectomy, or mesothelioma after extrapleural pneumonectomy 3) 6 weeks after pneumonectomy or 4 weeks after chemotherapy 4) Age; 20-75 years 5) ECOG PS; 0-1 6) Adequate organ functions; hemoglobin >= 9.0g/dl white blood cells >= 2,000/m3 platelets >= 100,000/m3 serum albumin >= 2.5g/dl AST/ALT <= 2.5 x ULN total bilirubin <= 1.5 x ULN SpO2/SaO2 in room air >= 95% ECG: within normal range 7) Life expectancy; longer than 12 weeks 8) Written informed consent
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of adverse events, protocol compliance rate, to estimate the maximum tolerating dose (MTD) and to determine the recommended dose (RD) | — |
Secondary
| Measure | Time frame |
|---|---|
| Median local control and estimation of chest pain | — |
Countries
Japan
Contacts
Public ContactTakeshi Ebara
Gunma University Department of Radiation Oncology, Gunma University Graduate School of Medicine
Outcome results
None listed