UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032423 |
|---|---|
| Receipt number | R000036973 |
| Scientific Title | Phase II study of additional indication on extreme hypofractionated stereotactic body radiation therapy for prostate cancer |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2022/03/26 12:54:48 |
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Basic information
Public title
Phase II study of additional indication on extreme hypofractionated stereotactic body radiation therapy for prostate cancer
Acronym
Phase II study of additional indication on extreme hypofractionated stereotactic body radiation therapy for prostate cancer
Scientific Title
Phase II study of additional indication on extreme hypofractionated stereotactic body radiation therapy for prostate cancer
Scientific Title:Acronym
Phase II study of additional indication on extreme hypofractionated stereotactic body radiation therapy 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 explore the safety and efficacy of extreme hypofractionated stereotactic body radiation therapy for localized prostate cancer expanded indication to high risk group
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of 5 year chronic adverse events
Key secondary outcomes
Incidence of acute adverse events, Incidence of 5 year biochemical failure free survival, Incidence of 5 year clinical failure free survival, Incidence of 5 year overall survival
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
| Device,equipment |
Interventions/Control_1
Extreme hypofractionated stereotactic body radiation therapy
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
| 50 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male
Key inclusion criteria
(1) Histologically proved prostate adenocarcinoma
(2) Low or intermediate or highg risk prostate cancer (T1-T3aN0M0 and PSA=<50 and GS:6-10)
(3) 50y.o. =< age =< 80 y.o.
(4) ECOG performance status 0-1
(5) Posible to insert fiducial gold markers
(6) Written informed consent
Key exclusion criteria
(1) Cancer patients with a duplication of activity
(2) Patients with severe or uncontrollable diabetes
(3) Serious medical complications (uncontrollable collagen disease, heart disease, interstitial pneumonia, liver cirrhosis, etc.)
(4) Mental diseases which prevent from registration of this trial
(5) History of pelvic radiation therapy
(6) History of pelvic surgery
(7) History of prostate surgery including TUR-P and HIFU
(8) History of chemotherapy for prostate cancer
(9) Patients with inflammatory bowel disease
(10) Patients treated with anticoagulant
(11) IPSS => 20
(12) Persons who are judged inappropriate by the researcher
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Akiba |
Organization
Tokai university school of medicine
Division name
Radiation oncology
Zip code
Address
143 shimokasuya isehara kanagawa japan
TEL
0463-93-1121
takiba@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Akiba |
Organization
Tokai university school of medicine
Division name
Radiation oncology
Zip code
Address
143 shimokasuya isehara kanagawa japan
TEL
0463-93-1121
Homepage URL
takiba@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai university
Institute
Department
Personal name
Funding Source
Organization
Tokai university
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
| 2018 | Year | 05 | 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
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
Terminated
Date of protocol fixation
| 2018 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | 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 | 28 | Day |
Last modified on
| 2022 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036973
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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