UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035606 |
|---|---|
| Receipt number | R000040049 |
| Scientific Title | A prospective cohort study of hypofractionated radiotherapy using 60Gy in 20 fractions for prostate cancer with IMRT/IGRT |
| Date of disclosure of the study information | 2019/01/22 |
| Last modified on | 2024/07/09 07:37:49 |
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Basic information
Public title
A prospective cohort study of hypofractionated radiotherapy using 60Gy in 20 fractions for prostate cancer with IMRT/IGRT
Acronym
A prospective cohort study of hypofractionated RT for prostate cancer
Scientific Title
A prospective cohort study of hypofractionated radiotherapy using 60Gy in 20 fractions for prostate cancer with IMRT/IGRT
Scientific Title:Acronym
A prospective cohort study of hypofractionated RT for prostate cancer
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the efficacy and toxicity of hypofractionated intensity-modulated radiation therapy (IMRT) with image-guided radiation therapy (IGRT) for prostate cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Five-year 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1) Primary adenocarcinoma of the prostate
2) T1c-T3bN0M0 (UICC TNM 8th Edition)
3) Age >= 20 years old
4) ECOG-PS 0-2
5) No previous pelvic radiotherapy
6) Fiducial marker guided prostate radiotherapy can be used
7) Written informed consent
Key exclusion criteria
1) Treated with brachytherapy
2) Received anti-androgen therapy for more than 1 year
3) After radical prostatectomy
4) Inflammatory bowel disease
5) Bilateral total hip arthroplasty
6) Synchronous or metachronous malignancies
7) Patients who attending physicians consider to be inappropriate due to other reasons mentioned above
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hisanori |
| Middle name | |
| Last name | Ariga |
Organization
Iwate medical university
Division name
Department of radiation oncology
Zip code
028-3685
Address
2-1-1, Idaidori, Yahaba-cho, Shiwa-gun, Iwate
TEL
019-613-7111
hariga2525@gmail.com
Public contact
Name of contact person
| 1st name | Koyo |
| Middle name | |
| Last name | Kikuchi |
Organization
Iwate medical university
Division name
Department of radiation oncology
Zip code
028-3685
Address
2-1-1, Idaidori, Yahaba-cho, Shiwa-gun, Iwate
TEL
019-613-7111
Homepage URL
kikuchi@iwate-med.ac.jp
Sponsor or person
Institute
Iwate medical university
Institute
Department
Personal name
Funding Source
Organization
Iwate medical university
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Iwate medical university
Address
1-1-1, Idaidori, Yahaba-cho, Shiwa-gun, Iwate
Tel
019-651-5111
kenkyu-rinri@j.iwate-med.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
| 2019 | Year | 01 | Month | 22 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 22 | Day |
Last follow-up date
| 2029 | Year | 01 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2019 | Year | 01 | Month | 21 | Day |
Last modified on
| 2024 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040049
