UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014671 |
|---|---|
| Receipt number | R000016877 |
| Scientific Title | Phase II study of hypofractionated stereotactic body radiation therapy for prostate cancer |
| Date of disclosure of the study information | 2014/07/28 |
| Last modified on | 2014/07/28 11:01:20 |
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Basic information
Public title
Phase II study of hypofractionated stereotactic body radiation therapy for prostate cancer
Acronym
Phase II study of hypofractionated stereotactic body radiation therapy for prostate cancer
Scientific Title
Phase II study of hypofractionated stereotactic body radiation therapy for prostate cancer
Scientific Title:Acronym
Phase II study of 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
The aim is to determine the efficacy of hypofractionated stereotactic body radiation therapy for localized prostate cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the incidence of delayed adverse events at 5 years
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
irradiation
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)adenocaricnoma of the prostate which was pathologically confirmed
2) low risk group or intermediate risk group (T1-T2c and PSA =<20 ng/mL and Gleason score =<7)
3)neoadjuvant hormonal therapy for 3-12 months has been undertaken in patients with intermediate risk group
4)age:>=50,<80 years
5)Performance status:0-1
6)gold markers have been inserted
7)informed consent has been obtained
Key exclusion criteria
1)Patients who have had any other cancer within the past 5 years
2)Patients who have uncontrollable diabetes mellitus
3)Patients who have serious comorbidities such as collagen disease, heart disease, interstitial pneumonia, liver cirrhosis
4)patients who have a psychological problem
5)patients who had previously received pelvic irradiation
6)patients who had previously received pelvic surgery
7)patients who had previously received TURP, orchiectomy, or HIFU
8)patients who had previously received chemotherapy for prostate cancer
9)patients who have Crohn's disease or ulcerative colitis
10)patients who require concomitant anticoagulant therapy
11)IPSS at registration>=20
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akitomo Sugawara |
Organization
Tokai University Hachioji Hospital
Division name
Radiation Oncology
Zip code
Address
1838 Ishikawa-machi, Hachioji, Tokyo
TEL
042-639-1111
h4411@wave.plala.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akitomo Sugawara |
Organization
Tokai University Hachioji Hospital
Division name
Radiation Oncology
Zip code
Address
1838 Ishikawa-machi, Hachioji, Tokyo
TEL
042-639-1111
Homepage URL
h4411@wave.plala.or.jp
Sponsor or person
Institute
Radiation Oncology, Tokai University Hachioji Hospital
Institute
Department
Personal name
Funding Source
Organization
N/A
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
| 2014 | Year | 07 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 05 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 29 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 28 | Day |
Last modified on
| 2014 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016877
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
