UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029201
Receipt number R000033378
Scientific Title Feasibility study of the respirately gated carbon-ion radiotherapy using the rotating gantry
Date of disclosure of the study information 2017/10/01
Last modified on 2019/09/28 13:10:14

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Basic information

Public title

Feasibility study of the respirately gated carbon-ion radiotherapy using the rotating gantry

Acronym

Respirately gated carbon-ion radiotherapy using the rotating gantry

Scientific Title

Feasibility study of the respirately gated carbon-ion radiotherapy using the rotating gantry

Scientific Title:Acronym

Respirately gated carbon-ion radiotherapy using the rotating gantry

Region

Japan


Condition

Condition

malignancy located chest or abdomen

Classification by specialty

Radiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the safety of respirately gated carbon-ion radiotherapy using the rotating gantry

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Acute adverse reaction ( within three months from the begining of the carbon ion radiotherapy)

Key secondary outcomes



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

Carbon-ion radiotherapy for the tumor located in the chest or abdomen

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1)The cancer of chest or abdomen which moves with respiration and is eligible for carbon-ion radiotherapy as a advanced medical technology A.
2)Performance status 0 or 1.
3)Patients who can understand and agree to this study by themselves.

Key exclusion criteria

1)Prognosis < 6 months
2)History of the severe complication
3)Active double cancers
4)History of the radiotherapy to the same region
5)Severe infection of the treatment area
6)Severe clinical condition

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Naoyoshi
Middle name
Last name Yamamoto

Organization

National Institute of Quantum and Radiological Science and Technology

Division name

Hospital of the National Institute of Radilogical Sciences

Zip code

263-8555

Address

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

TEL

043-206-3360

Email

yamamoto.naoyoshi@qst.go.jp


Public contact

Name of contact person

1st name Naoyoshi
Middle name
Last name Yamamoto

Organization

National Institute of Quantum and Radiological Science and Technology

Division name

Hospital of the National Institute of Radilogical Sciences

Zip code

263-8555

Address

Anagawa 4-9-1, Inage-ku 263-8555 Chiba, Japan

TEL

043-206-3360

Homepage URL


Email

yamamoto.naoyoshi@qst.go.jp


Sponsor or person

Institute

Hospital of the National Institute of Radilogical Sciences, National Institute of Quantum and Radiological Science and Technology

Institute

Department

Personal name



Funding Source

Organization

Hospital of the National Institute of Radilogical Sciences, National Institute of Quantum and Radiological Science and 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

IRB of the National Institute of Radilogical Sciences, National Institute of Quantum and Radiological Science and Technology

Address

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

Tel

043-206-4709

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 10 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

10

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

Completed

Date of protocol fixation

2017 Year 09 Month 04 Day

Date of IRB

2017 Year 09 Month 04 Day

Anticipated trial start date

2017 Year 10 Month 01 Day

Last follow-up date

2019 Year 08 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 09 Month 20 Day

Last modified on

2019 Year 09 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033378


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name