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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010510
Receipt No. R000012292
Official scientific title of the study Phase II clinical trial of hypofractionated radiotherapy using proton beams for prostate cancer
Date of disclosure of the study information 2013/04/16
Last modified on 2016/06/01

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Basic information
Official scientific title of the study Phase II clinical trial of hypofractionated radiotherapy using proton beams for prostate cancer
Title of the study (Brief title) Hypofractionated proton 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 examine the feasibility and efficacy of hypofractionated proton beam radiotherapy for prostate cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 5-year rate of Grade 2 or worse late toxicity
Key secondary outcomes Acute and late toxicity rate, biochemical relapse-free rate, overall survival rate, cause-specific survival rate, and clinical relapse-free survival rate

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
Maneuver
Interventions/Control_1 70Gyin 28fraction with a fractional dose of 2.5Gy
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
80 years-old >
Gender Male
Key inclusion criteria Patients who
1) consent to participate this study.
2) are 20-79 years old
3) have prostate adenocarinoma clinically staged with T1c-T3aN0M0
4) agree to receive a scheduled therapy according to the tumor risk group
Key exclusion criteria Patients who
1) have lymph node metastasis
2) have distant metastasis
3) severe comcomitant diseases such as active infection, heart failure and myocardial infarction, severe respiratory dysfunction, renal faiure, and uncotrolled diabetes mellitus
Target sample size 102

Research contact person
Name of lead principal investigator Hideyuki Sakurai
Organization University of Tsukuba
Division name Proton Medical Research Center
Address 1-1-1, Tennodai, Tsukuba
TEL 029-853-7100
Email hsakurai@pmrc.tsukuba.ac.jp

Public contact
Name of contact person Hitoshi Ishikawa
Organization University of Tsukuba
Division name Proton Medical Research Center
Address 1-1-1, Tennodai, Tsukuba
TEL 029-853-7100
Homepage URL
Email hishikawa@pmrc.tsukuba.ac.jp

Sponsor
Institute Proton Medical Research Center, University of Tsukuba
Institute
Department

Funding Source
Organization Proton Medical Research Center, University of Tsukuba
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 筑波大学附属病院

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 16 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2013 Year 04 Month 10 Day
Anticipated trial start date
2013 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2013 Year 04 Month 16 Day
Last modified on
2016 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012292

Research Plan
Registered date Registrant File name

Research case data specifications
Registered date Registrant File name

Research case data
Registered date Registrant File name


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