UMIN-CTR Clinical Trial

Basic information
Public title	Inter-fractional margin using respiratory gated for the patients with prostate cancer
Acronym	Inter-fractional margin using respiratory gated for the patients with prostate cancer
Scientific Title	Inter-fractional margin using respiratory gated for the patients with prostate cancer
Scientific Title:Acronym	Inter-fractional margin using respiratory gated for the patients with prostate cancer
Region	Japan

Condition
Condition	Prostate cancer
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the change of organ locations and dose distribution in each irradiation for the patients with prostate cancer treated with carbon ion radiotherapy
Basic objectives2	Others
Basic objectives -Others	The comparison of the DVH parameter of rectum and bladder using the calcurated margine
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	inter-fractional margin of the prostate and seminal vesicle
Key secondary outcomes	The comparison of the DVH parameter of rectum and bladder using the calcurated margine

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	Not applicable
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	The prostate cancer patients treated with 12 fractionated carbon ion radiotherapy
Key exclusion criteria	The patients who rejected the informed concent
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Goro Middle name Last name Kasuya
Organization	QST hospital
Division name	Treatment department
Zip code	263-8555
Address	4-9-1 anagawa Inage-ku Chiba
TEL	+81-43-206-3306
Email	kasuya.goro@qst.go.jp

Public contact
Name of contact person	1st name Goro Middle name Last name Kasuya
Organization	QST hospital
Division name	Treatment department
Zip code	263-8555
Address	4-9-1 anagawa Inage-ku Chiba
TEL	+81-43-206-3306
Homepage URL
Email	kasuya.goro@qst.go.jp

Sponsor
Institute	Ministry of Education
Institute
Department

Funding Source
Organization	Ministry of Education
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	National Institutes for Quantum and Radiological Science a nd Technology Certified Review Board
Address	4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba
Tel	043-206-4706
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	2020 Year 06 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
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	2020 Year 05 Month 18 Day
Date of IRB	2020 Year 05 Month 29 Day
Anticipated trial start date	2020 Year 06 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The calucuration of inter-fractional margin and the DVH analyses

Management information
Registered date	2020 Year 06 Month 12 Day
Last modified on	2022 Year 06 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046513