UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022570 |
|---|---|
| Receipt number | R000026015 |
| Scientific Title | Phase II trial of hypofractionated intensity modulated radiotherapy in patients with low risk prostate cancer |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2020/12/10 10:53:01 |
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Basic information
Public title
Phase II trial of hypofractionated intensity modulated radiotherapy in patients with low risk prostate cancer
Acronym
HiMRT-P2
Scientific Title
Phase II trial of hypofractionated intensity modulated radiotherapy in patients with low risk prostate cancer
Scientific Title:Acronym
HiMRT-P2
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the safety and efficacy of hypofractionated intensity modulated radiotherapy for localized prostate cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cumulative toxicity rate at 3 years after treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
radiotherapy
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
pathological confirmation
<=T3bN0M0
age>=20 y.o.
PS=0 or 1
no history of pelvic irradiation
normal general condition
informed consent
Key exclusion criteria
no psychological disease
no long term steroid prescription
severe diabetes mellitus
no active infection
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kasushige Hayakawa |
Organization
Kitasato University school of medicine
Division name
department of radiology and radiation oncology
Zip code
Address
1-15-1 kitasato sagamiharashi-minamiku
TEL
042-778-8453
hayakaz@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | hiromichi ishiyama |
Organization
kitasato university shool of medicine
Division name
department of radiology and radiation oncology
Zip code
Address
1-15-1 kitasato sagamiharashi-minamiku
TEL
042-778-8453
Homepage URL
hishiyam@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato university
Institute
Department
Personal name
Funding Source
Organization
na
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 06 | Month | 01 | 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
55
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
| 2015 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 26 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 06 | Month | 01 | Day |
Last modified on
| 2020 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026015
