UMIN-CTR Clinical Trial

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