UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022951 |
|---|---|
| Receipt number | R000026456 |
| Scientific Title | Hypofractionated intensity-modulated radiation therapy for prostate cancer |
| Date of disclosure of the study information | 2016/06/30 |
| Last modified on | 2019/03/31 15:20:34 |
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Basic information
Public title
Hypofractionated intensity-modulated radiation therapy for prostate cancer
Acronym
Hypofractionated intensity-modulated radiation therapy for prostate cancer
Scientific Title
Hypofractionated intensity-modulated radiation therapy for prostate cancer
Scientific Title:Acronym
Hypofractionated intensity-modulated 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 evaluate safety of hypofractionated IMRT for prostate cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ratio of 2-year late adverse events
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
| Maneuver |
Interventions/Control_1
Radiotherapy with 62 Gy delivered at 3.1 Gy/fraction
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) Patients with performance status(ECOG) of 0 or 1.
2) Patients with histologically confirmed prostate adenocarcinoma.
3) T1-T3aN0M0
4) Patients who give a written informed consent obtained.
Key exclusion criteria
1) Patients who received radiotherapy for prostate.
2) Patients who received surgery for prostate.
3) Patients with uncontrolled active infection.
4) Cancer patients with a duplication of activity.
5) Patients with serious complications (uncontrollable collagen disease, heart disease, pulmonary disease, liver disease).
6) Mental diseases which prevent from registration of this trial.
7) Patients who received chemotherapy for prostate cancer.
8) Patients with inflammatory bowel disease.
9) Patients with severe or uncontrollable diabetes mellitus.
10) Risk organs are too close to the PTV to keep dose constraints.
11) Patients judged inappropriate for this study by the physicians.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eisuke Abe |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Radiation Oncology
Zip code
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata
TEL
025-227-2315
eabe@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eisuke Abe |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Radiation Oncology
Zip code
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata
TEL
025-227-2315
Homepage URL
eabe@med.niigata-u.ac.jp
Sponsor or person
Institute
Department of Radiation Oncology, Graduate School of Medical and Dental Sciences, Niigata University
Institute
Department
Personal name
Funding Source
Organization
None
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
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 | 30 | 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
39
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
| 2014 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2019 | 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
| 2016 | Year | 06 | Month | 30 | Day |
Last modified on
| 2019 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026456
| 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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| Registered date | File name |
