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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003838
Receipt No. R000004624
Official scientific title of the study A phase I/II clinical trial of carbon-ion radiotherapy in 12 fractions for prostate cancer
Date of disclosure of the study information 2010/07/01
Last modified on 2016/11/01

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Basic information
Official scientific title of the study A phase I/II clinical trial of carbon-ion radiotherapy in 12 fractions for prostate cancer
Title of the study (Brief title) 12-fractionation carbon-ion RT 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 assess safety and efficacy of carbon-ion radiotherapy in 12 fractions for prostate cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes incidence of late radiation toxicity
Key secondary outcomes relapse-free survival rate, overall survival rate, cause-specific survival rate, quality of life assessment

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 carbon-ion radiotherapy in 12 fractions
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

Not applicable
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria 1)pathologically confirmed prostate cancer
2)T1b,T1c,T2a,T2b,T2c,T3a, or T3b, and M0
in UICC TNM classification in 2009
3)clinically N0 (by imaging) or pathologically N0 or N1 (in 1992 UICC, solitary positive node less than 2cm in diameter)
4)signed consent form
Key exclusion criteria 1)previous radiation therapy for pelvis
2)expected survival period < 6 months
3)Performance status worse than 2
4)previous treatment other than hormonal therapy for prostate cancer
5)concurrent other malignancy
6)active infection in pelvis
7)not inclusive because of other serious medical or psychological problem
Target sample size 45

Research contact person
Name of lead principal investigator Jun Shimazaki
Organization National Institute of Radiological Sciences
Division name Research center for charged particle therapy
Address 4-9-1 Anagawa, Inage-ku, Chiba 263-8555, Japan
TEL 043-206-3350
Email h_tsuji@nirs.go.jp

Public contact
Name of contact person Hiroshi Tsuji
Organization National Institute of Radiological Sciences
Division name Research center for charged particle therapy
Address 4-9-1 Anagawa, Inage-ku, Chiba 263-8555, Japan
TEL 043-206-3350
Homepage URL
Email h_tsuji@nirs.go.jp

Sponsor
Institute National Institute of Radiological Sciences, Network congress of charged particle therapy
Institute
Department

Funding Source
Organization Japanese ministry of education, culture, sports, science and technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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 放射線医学総合研究所(千葉県)

Other administrative information
Date of disclosure of the study information
2010 Year 07 Month 01 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2010 Year 06 Month 10 Day
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2017 Year 06 Month 01 Day
Date of closure to data entry
2018 Year 03 Month 01 Day
Date trial data considered complete
2018 Year 03 Month 01 Day
Date analysis concluded
2018 Year 03 Month 01 Day

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

Management information
Registered date
2010 Year 06 Month 29 Day
Last modified on
2016 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004624

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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