UMIN-CTR Clinical Trial

Basic information
Public title	Long-term outcome of carbon ion radiotherapy for elderly pancreatic cancer patients
Acronym	Carbon ion radiotherapy for elderly pancreatic cancer patients
Scientific Title	Long-term outcome of carbon ion radiotherapy for elderly pancreatic cancer patients
Scientific Title:Acronym	Carbon ion radiotherapy for elderly pancreatic cancer patients
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the efficacy and safety of carbon ion radiotherapy for elderly pancreatic cancer patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	3-year overall survival
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	80 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Elderly patients aged 80 years or more treated with carbon ion radiotherapy between November 2017 to December 2018.
Key exclusion criteria	None
Target sample size	46

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Last name Shinoto
Organization	National Institutes for Quantum and Radiological Science and Technology
Division name	QST Hospital
Zip code	2638555
Address	4-9-1 Anagawa, Inage-ku, Chiba,
TEL	0432063306
Email	shinoto.makoto@qst.go.jp

Public contact
Name of contact person	1st name Makoto Middle name Last name Shinoto
Organization	National Institutes for Quantum and Radiological Science and Technology
Division name	QST Hospital
Zip code	2638555
Address	4-9-1 Anagawa, Inage-ku, Chiba,
TEL	0432063306
Homepage URL
Email	shinoto.makoto@qst.go.jp

Sponsor
Institute	National Institutes for Quantum and Radiological Science and Technology
Institute
Department

Funding Source
Organization	Self fundign
Organization
Division
Category of Funding Organization	Self funding
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 and Technology
Address	4-9-1 Anagawa, Inage-ku, Chiba,
Tel	0432064706
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 10 Month 30 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	46
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 10 Month 15 Day
Date of IRB	2020 Year 10 Month 15 Day
Anticipated trial start date	2020 Year 10 Month 15 Day
Last follow-up date	2020 Year 12 Month 25 Day
Date of closure to data entry	2021 Year 10 Month 31 Day
Date trial data considered complete	2021 Year 10 Month 31 Day
Date analysis concluded	2021 Year 10 Month 31 Day

Other
Other related information	retrospective observative study

Management information
Registered date	2020 Year 10 Month 29 Day
Last modified on	2021 Year 10 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000048277