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

Completed

• 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

Study Timeline

• Study Start: 2010-08-23
• Study Completion: 2015-08-01
• Last Update Posted: 2023-10-17

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