UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024709
Receipt No. R000028427
Scientific Title Nationwide registration and clinical evaluation of the heavy particle beam therapy studies.
Date of disclosure of the study information 2016/11/04
Last modified on 2017/11/07

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Nationwide registration and clinical evaluation of the heavy particle beam therapy studies.
Acronym Nationwide registration and clinical evaluation of the heavy particle beam therapy studies.
Scientific Title Nationwide registration and clinical evaluation of the heavy particle beam therapy studies.
Scientific Title:Acronym Nationwide registration and clinical evaluation of the heavy particle beam therapy studies.
Region
Japan

Condition
Condition Head and Neck
Lung
Esophagus
Lower gastrointestinal tract
Hepato-biliary-pancreatic
Urinary organ
mammary-uterine-cervix
Bone and Soft tissue
Metastatic disease
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 1. Construction of the Database for heavy particle beam therapy studies.
2. Evaluation of the safety and efficacy of heavy particle radiation therapy for each disease, and conduction of the data analysis and so on that will contribute to the reporting of heavy particle radiation therapy insurance over the long term.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes survival rate
Key secondary outcomes Local control period
Progression-free survival
Adverse event
Evaluation of Quality of Life

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 and Female
Key inclusion criteria All cases receiving heavy particle radiation therapy in each collaborative research institute will be covered from 1 May 2016 to 31 March 2021.
Key exclusion criteria If patients or their families refuse to provide materials for this research, they are excluded.
Target sample size 999

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadashi Kamada
Organization National Institutes for Quantum and Radiological Science and Technology
Division name National Institute of Radiological Sciences
Zip code
Address 4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba 263-8555, Japan
TEL 043-206-3300
Email kamada.tadashi@qst.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuo Okuda
Organization National Institutes for Quantum and Radiological Science and Technology
Division name National Institute of Radiological Sciences
Zip code
Address 4-9-1 Anagawa, Inage-ku, Chiba-shi, Chiba 263-8555, Japan
TEL 043-206-3300
Homepage URL
Email okuda.yasuo@qst.go.jp

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

Funding Source
Organization MEXT(Japan)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 放射線医学総合研究所(千葉県)、兵庫県立粒子線医療センター(兵庫県)、群馬大学医学部附属病院(群馬県)、神奈川県立がんセンター(神奈川県)、九州国際重粒子線がん治療センター(佐賀県)

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 04 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 Enrolling by invitation
Date of protocol fixation
2016 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1. This study is a forward vision observation study, and there is no invasion / intervention of the subject by this research.
2. The subjects will be all cases receiving heavy particle radiation therapy at each collaborative research institution from May 1, 2016 to March 31, 2021.
3. We will disclose information at each facility and target cases that did not refuse to provide materials.

Management information
Registered date
2016 Year 11 Month 04 Day
Last modified on
2017 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028427

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.