UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004066
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Dose escalation study of intensity-modulated radiotherapy (IMRT) for ipsilateral intrathoracic recurrence after pneumonectomy (lung cancer/mediastinal tumor) or mesothelioma after extrapleural pneumonectomy
Acronym Dose escalation study of intensity-modulated radiotherapy (IMRT) for thoracic malignancy after pneumonectomy (TOMO-0801)
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
Scientific Title:Acronym Dose escalation study of intensity-modulated radiotherapy (IMRT) for thoracic malignancy after pneumonectomy (TOMO-0801)
Region
Japan

Condition
Condition Recurrence of thoracic malignancy (lung cancer/mediastinal tumor), or mesothelioma
Classification by specialty
Pneumology Chest surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 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)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Rate of adverse events, protocol compliance rate, to estimate the maximum tolerating dose (MTD) and to determine the recommended dose (RD)
Key secondary outcomes Median local control and estimation of chest pain

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Intensity-modulated radiotherapy (IMRT)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key 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
Key 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
Target sample size 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Ebara
Organization Gunma University
Division name Department of Radiation Oncology, Gunma University Graduate School of Medicine
Zip code
Address 3-39-22 Showa-machi, Maebashi, Gunma 371-8511, JAPAN
TEL 027-220-8383
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Ebara
Organization Gunma University
Division name Department of Radiation Oncology, Gunma University Graduate School of Medicine
Zip code
Address 3-39-22 Showa-machi, Maebashi, Gunma 371-8511, JAPAN
TEL 027-220-8383
Homepage URL
Email tebara@med.gunma-u.ac.jp

Sponsor
Institute Department of Radiation Oncology, Gunma University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Hidaka Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 日高病院(群馬県)
Hidaka Hospital (Gunma)

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 23 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2010 Year 07 Month 28 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
2015 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 08 Month 18 Day
Last modified on
2014 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004898

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.