UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032340 |
|---|---|
| Receipt number | 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 | 2024/01/29 16:08:09 |
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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 | Hiroshi |
| Middle name | |
| Last name | Tsuji |
Organization
QST Hospital, National Institutes for Quantum and Radiological Science and Technology
Division name
Treatment division
Zip code
263-8555
Address
4-9-1 Anagawa, Inage, Chiba
TEL
043-206-3306
kasuya.goro@qst.go.jp
Public contact
Name of contact person
| 1st name | Goro |
| Middle name | |
| Last name | Kasuya |
Organization
QST Hospital , National Institutes for Quantum and Rad
Division name
Treatment division
Zip code
263-8555
Address
4-9-1 Anagawa, Inage, Chiba
TEL
043-206-3306
Homepage URL
kasuya.goro@qst.go.jp
Sponsor or person
Institute
Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Science and Technology
Institute
Department
Personal name
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
National Institutes for Quantum and Radiolog ical Science and Technolog y
Address
4-9-1 Anagawa, Inage Ward, Chiba-City
Tel
043-206-4706
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
| 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
60
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
| 2018 | Year | 04 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 30 | Day |
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
| 2024 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036875
