UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029022
Receipt number R000033196
Scientific Title Multi-innstitutional retrospective study of carbon-ion radiotherapy for metastatic lung tumor
Date of disclosure of the study information 2017/09/13
Last modified on 2020/03/11 16:38:39

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Basic information

Public title

Multi-innstitutional retrospective study of carbon-ion radiotherapy for metastatic lung tumor

Acronym

Multi-innstitutional retrospective study of carbon-ion radiotherapy for metastatic lung tumor

Scientific Title

Multi-innstitutional retrospective study of carbon-ion radiotherapy for metastatic lung tumor

Scientific Title:Acronym

Multi-innstitutional retrospective study of carbon-ion radiotherapy for metastatic lung tumor

Region

Japan


Condition

Condition

metastatic lung tumor

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate retrospectively the results of carbon-ion radiotherapy for metastatic lung tumor from multi-instituton in Japan

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

local control rate

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Metastaic tumor treated by carbon-ion radiotherapy
2)Tumor had to be measurable
3)The number of lesions in the lung is three or less
4)No reccurent tumor in another organ

Key exclusion criteria

1)The case of carbon-ion re-irradiation
2)The case with interstitial pneumonia
3)The case had another primary cancer

Target sample size

100


Research contact person

Name of lead principal investigator

1st name NAOYOSHI
Middle name
Last name YAMAMOTO

Organization

National Institute of Radiorogical Sciences
National Institute of Quantam and Radiological Scienceand technology

Division name

Hospital

Zip code

263-8555

Address

4-9-1 Anagawa, Inage-ku, Chiba city, Chiba, Japan

TEL

043-206-3306

Email

yamamoto.naoyoshi@qst.go.jp


Public contact

Name of contact person

1st name NAOYOSHI
Middle name
Last name YAMAMOTO

Organization

National Institute of Radiorogical Sciences

Division name

Hospital

Zip code

263-8555

Address

4-9-1 Anagawa, Inage-ku, Chiba city, Chiba, Japan

TEL

043-206-3306

Homepage URL


Email

yamamaoto.naoyoshi@qst.go.jp


Sponsor or person

Institute

National Institute of Radiorogical Sciences
National Institute of Quantam and Radiological Scienceand technology

Institute

Department

Personal name



Funding Source

Organization

National Institute of Radiorogical Sciences
National Institute of Quantam and Radiological Scienceand technology

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Institute of Radiorogical Sciences Institutional Review Board

Address

4-9-1 Anagawa, Inage-ku, Chiba city, Chiba, Japan

Tel

043-206-3306

Email

helsinki@qst.go.jp


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



Other administrative information

Date of disclosure of the study information

2017 Year 09 Month 13 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

113

Results


Results date posted

2020 Year 03 Month 11 Day

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

Completed

Date of protocol fixation

2017 Year 07 Month 19 Day

Date of IRB

2017 Year 07 Month 19 Day

Anticipated trial start date

2017 Year 10 Month 13 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2017 Year 09 Month 06 Day

Last modified on

2020 Year 03 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033196


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name