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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032340
Receipt No. R000036875
Scientific Title A Phase I/II trial of radical carbon-ion radiotherapy using 4 fractions for the patients with low- or intermediate-risk prostate cancer
Date of disclosure of the study information 2018/05/10
Last modified on 2018/05/31

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Basic information
Public title A Phase I/II trial of radical carbon-ion radiotherapy using 4 fractions for the patients with low- or intermediate-risk prostate cancer
Acronym Radical carbon-ion radiotherapy using 4 fractions for prostate cancer
Scientific Title A Phase I/II trial of radical carbon-ion radiotherapy using 4 fractions for the patients with low- or intermediate-risk prostate cancer
Scientific Title:Acronym Radical carbon-ion radiotherapy using 4 fractions for prostate cancer
Region
Japan

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

Objectives
Narrative objectives1 To evaluate safety and efficacy of carbon-ion radiotherapy using 4 fractions for the patients with low- or intermediate-risk prostate cancer. To determine appropriate total dose and treatment schedulle (one or two week)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes GI/GU adverse event
Key secondary outcomes Biochemical failure free survival, overall survival, disease free survival, dose volume analysis, and evaluation of QOL

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Pescription dose is started from 36 Gy (RBE)/4fraction. 10 patients are treated in "one-week" groups. If DLT (acute grade 3 or more adverse events) is observed in less than 3 patients, dose-escalation is performed.
Interventions/Control_2 Pescription dose is started from 36 Gy (RBE)/4fraction. 10 patients are treated in "two-weeks" groups. If DLT (acute grade 3 or more adverse events) is observed in less than 3 patients, dose-escalation is performed.
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 1) biopsy-proven prostate cancer
2) -T2cN0M0, PSA < 20 ng/ml, GS =<7 according to MRI, CT and bone scintigram
3) Performance Status (ECOG) of 0-1.
4) Expected prognosis > 6 months
5) Approved by document.
Key exclusion criteria 1) Other therapies except for hormonal therapy
2) Previous radiation therapy to the pelvis
3) Ineligible dose constraints of risk organs
4) Castration resistant prostate cancer
5) Previous TUR-P
6) Active Double cancer
7) Presence of active double cancer
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuji Hiroshi
Organization Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Science and Technology
Division name Treatment division
Zip code
Address 4-9-1 Anagawa, Inage, Chiba
TEL 043-206-3306
Email tsuji.hiroshi@qst.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kasuya Goro
Organization Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Rad
Division name Treatment division
Zip code
Address 4-9-1 Anagawa, Inage, Chiba
TEL 043-206-3306
Homepage URL
Email kasuya.goro@qst.go.jp

Sponsor
Institute Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Science and Technology
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
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

Other administrative information
Date of disclosure of the study information
2018 Year 05 Month 10 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 Open public recruiting
Date of protocol fixation
2018 Year 04 Month 11 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 04 Month 22 Day
Last modified on
2018 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036875

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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