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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021645
Receipt No. 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

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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
Email 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
Email koinaba@ncc.go.jp

Sponsor
Institute Department of Radiation Oncology, National Cancer Center Hospital, Japan
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024941

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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