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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003827
Receipt No. R000004611
Official scientific title of the study Efficacy and safety of carbon ion radiotherapy in 16 fractionations for prostate cancer
Date of disclosure of the study information 2010/06/25
Last modified on 2011/12/26

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Basic information
Official scientific title of the study Efficacy and safety of carbon ion radiotherapy in 16 fractionations for prostate cancer
Title of the study (Brief title) carbon ion radiotherapy for prostate cancer (16 fractionations)
Region
Japan

Condition
Condition Prostate cancer
Classification by specialty
Urology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To confirm efficacy and safety of 16 fractionated carbon ion radiotherapy for T1c-T3N0M0 prostae cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Biochemocal relapse-free rate at 5 years
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 1) Histologically confirmed prostate cancer (adenocarcinoma)
2) Gleason score was confirmed
3) T1cN0M0 (UICC 6th, 2002)
4) PSA before biopsy was confirmed
5) Age 20-80
6) PS 0-2
7) informed concent was given
Key exclusion criteria 1) History of pelvic irradiation
2) History of TUR-Bt or HIFU
3) HIstory of chemotherapy 4 weeks before treatment
4) life expectancy less than 6 months
5) Active double cancer
6) neoadjuvant hormonal therapy more than 8 months
7) hormone-refractory prostate cancer
8) difficulty with planned hormonal therapy
9) Corticosteroid or antiandrogen therapy for concomitant disease
10) severe comcomitant disease
11) other medically or psychologically unsuitable reasons
Target sample size 130

Research contact person
Name of lead principal investigator Takashi Nakano
Organization Gunma University
Division name Gunma University Heavy Ion Medical Center
Address 3-39-22 Showa, Maebashi, Gunma 371-8511
TEL
Email

Public contact
Name of contact person
Organization Gunma University
Division name Gunma University Heavy Ion Medical Center
Address
TEL 027-220-8378
Homepage URL
Email

Sponsor
Institute Gunma University Heavy Ion Medical Center
Institute
Department

Funding Source
Organization MEXT
Organization
Division
Category of Funding Organization
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

Other administrative information
Date of disclosure of the study information
2010 Year 06 Month 25 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2010 Year 05 Month 12 Day
Anticipated trial start date
2010 Year 06 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 Prospective study

Management information
Registered date
2010 Year 06 Month 25 Day
Last modified on
2011 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004611

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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