Unique ID issued by UMIN | UMIN000004066 |
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Receipt number | R000004898 |
Scientific Title | Dose escalation study of intensity-modulated radiotherapy (IMRT) for ipsilateral intrathoracic recurrence after pneumonectomy (lung cancer/mediastinal tumor) or mesothelioma after extrapleural pneumonectomy |
Date of disclosure of the study information | 2010/08/23 |
Last modified on | 2014/03/07 13:11:03 |
Dose escalation study of intensity-modulated radiotherapy (IMRT) for ipsilateral intrathoracic recurrence after pneumonectomy (lung cancer/mediastinal tumor) or mesothelioma after extrapleural pneumonectomy
Dose escalation study of intensity-modulated radiotherapy (IMRT) for thoracic malignancy after pneumonectomy (TOMO-0801)
Dose escalation study of intensity-modulated radiotherapy (IMRT) for ipsilateral intrathoracic recurrence after pneumonectomy (lung cancer/mediastinal tumor) or mesothelioma after extrapleural pneumonectomy
Dose escalation study of intensity-modulated radiotherapy (IMRT) for thoracic malignancy after pneumonectomy (TOMO-0801)
Japan |
Recurrence of thoracic malignancy (lung cancer/mediastinal tumor), or mesothelioma
Pneumology | Chest surgery | Radiology |
Malignancy
NO
To evaluate the toxicities of intensity-modulated radiotherapy (IMRT) to ipsilateral intrathoracic recurrence after pneumonectomy (lung cancer/mediastinal tumor), or mesothelioma after extrapleural pneumonectomy, and to determine the maximum tolerated dose (MTD) and to determine the recommended dose (RD)
Safety,Efficacy
Pragmatic
Phase I
Rate of adverse events, protocol compliance rate, to estimate the maximum tolerating dose (MTD) and to determine the recommended dose (RD)
Median local control and estimation of chest pain
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
Intensity-modulated radiotherapy (IMRT)
20 | years-old | <= |
75 | years-old | > |
Male and Female
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
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
9
1st name | |
Middle name | |
Last name | Takeshi Ebara |
Gunma University
Department of Radiation Oncology, Gunma University Graduate School of Medicine
3-39-22 Showa-machi, Maebashi, Gunma 371-8511, JAPAN
027-220-8383
1st name | |
Middle name | |
Last name | Takeshi Ebara |
Gunma University
Department of Radiation Oncology, Gunma University Graduate School of Medicine
3-39-22 Showa-machi, Maebashi, Gunma 371-8511, JAPAN
027-220-8383
tebara@med.gunma-u.ac.jp
Department of Radiation Oncology, Gunma University Graduate School of Medicine
None
Self funding
Japan
Hidaka Hospital
NO
日高病院(群馬県)
Hidaka Hospital (Gunma)
2010 | Year | 08 | Month | 23 | Day |
Unpublished
Terminated
2010 | Year | 07 | Month | 28 | Day |
2010 | Year | 08 | Month | 01 | Day |
2015 | Year | 08 | Month | 01 | Day |
2010 | Year | 08 | Month | 18 | Day |
2014 | Year | 03 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004898
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