UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033172 |
|---|---|
| Receipt number | R000037830 |
| Scientific Title | A registry of Nation Japanese Radiation Oncology Study Group: Intensity-modulated radiation therapy for prostate cancer |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2024/12/20 15:37:39 |
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Basic information
Public title
A registry of Nation Japanese Radiation Oncology Study Group: Intensity-modulated radiation therapy for prostate cancer
Acronym
JROSG-IMRT-PC01
Scientific Title
A registry of Nation Japanese Radiation Oncology Study Group: Intensity-modulated radiation therapy for prostate cancer
Scientific Title:Acronym
JROSG-IMRT-PC01
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the feasibility and efficacy of intensity-modulated radiation therapy for localized prostate cancer in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5-year rate of biochemical relapse free survival
Key secondary outcomes
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
Key inclusion criteria
Patients who
1)must be diagnosed as prostate cancer pathologically
2)have prostate adenocarinoma clinically staged with T1c-T4N0M0
3)must be at a score level of 70-100 of KPS; Karnofsky performance status
Key exclusion criteria
Patients who
1)have existence of any treatment, excluding androgen deprivation therapy for prostate cancer.
2)have active double cancer (synchronous double cancer and metachronous double cancer within 5 disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment.
3)have history of pelvis irradiation
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | HIDEYUKI |
| Middle name | hayashi, |
| Last name | Sakurai |
Organization
University of Tsukuba, Faculty of Medicine
Division name
Radiation Oncology
Zip code
3058576
Address
1-1-1, Tennodai, Tsukuba
TEL
029-853-7100
hsakurai@pmrc.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | hayashi, |
| Last name | Ishikawa |
Organization
University of Tsukuba, Faculty of Medicine
Division name
Radiation Oncology
Zip code
3058576
Address
1-1-1, Tennodai, Tsukuba
TEL
029-853-7100
Homepage URL
hishikawa@pmrc.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba, Proton Medical Research Center
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
Ethical Committee, University of Tsukuba Hospital
Address
2-1-1 Amakubo Tsukuba Ibaraki Japan
Tel
0298537562
rinsyokenkyuu@un.tsukuba.ac.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 | 07 | 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
1037
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Comparative analysis with results of historically or simultaneously performed studies of proton beam therapy, carbon-ion beam therapy, or surgery will be carried out.
Management information
Registered date
| 2018 | Year | 06 | Month | 28 | Day |
Last modified on
| 2024 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037830
