UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021645 |
|---|---|
| Receipt number | R000024941 |
| Scientific Title | Phase II study of single fraction HDR combined with whole pelvic IMRT for prostate cancer |
| Date of disclosure of the study information | 2016/03/27 |
| Last modified on | 2016/04/11 09:29:16 |
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Basic information
Public title
Phase II study of single fraction HDR combined with whole pelvic IMRT for prostate cancer
Acronym
Phase II study of single fraction HDR combined with whole pelvic IMRT for prostate cancer
Scientific Title
Phase II study of single fraction HDR combined with whole pelvic IMRT for prostate cancer
Scientific Title:Acronym
Phase II study of single fraction HDR combined with whole pelvic IMRT for prostate cancer
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safety,Efficacy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
The rate of chronic adverse events
Key secondary outcomes
5 year PSA relapse free survival, 5 year clinical relapse free survival, 5 year overall survival, the rate of acute adverse events
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
| Other |
Interventions/Control_1
Radiation therapy(High dose rate intersitial brachytherapy 15 Gy*1fraction+External beam radiation)
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.Prostate cancer
2.High risk
3.PS 0-1
Key exclusion criteria
1.Synchronous malignancies
2.Past medical history of pelvic radiotherapy
3.Past medical history of surgery, HIFU, and chemotherapy for prostate cancer
4.Inflammatory bowel disease such as Crohn disease or ulcerative colitis
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Itami |
Organization
National Cancer Center Hospital, Japan
Division name
Department of Radiation Oncology
Zip code
Address
5-1-1,Tsukiji,Chuo-ku,Tokyo,Japan
TEL
03-3542-2511
jitami@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Inaba |
Organization
National Cancer Center Hospital, Japan
Division name
Department of Radiation Oncology
Zip code
Address
5-1-1,Tsukiji,Chuo-ku,Tokyo,Japan
TEL
03-3542-2511
Homepage URL
koinaba@ncc.go.jp
Sponsor or person
Institute
Department of Radiation Oncology, National Cancer Center Hospital, Japan
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 | 03 | Month | 27 | 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
| 2016 | Year | 01 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 10 | 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
| 2016 | Year | 03 | Month | 27 | Day |
Last modified on
| 2016 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024941
