UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004066
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

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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 or person

Institute

Department of Radiation Oncology, Gunma University Graduate School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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