UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003838 |
|---|---|
| Receipt number | R000004624 |
| Scientific Title | 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 14:02:49 |
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Basic information
Public title
A phase I/II clinical trial of carbon-ion radiotherapy in 12 fractions for prostate cancer
Acronym
12-fractionation carbon-ion RT for prostate cancer
Scientific Title
A phase I/II clinical trial of carbon-ion radiotherapy in 12 fractions for prostate cancer
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Jun Shimazaki |
Organization
National Institute of Radiological Sciences
Division name
Research center for charged particle therapy
Zip code
Address
4-9-1 Anagawa, Inage-ku, Chiba 263-8555, Japan
TEL
043-206-3350
h_tsuji@nirs.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Tsuji |
Organization
National Institute of Radiological Sciences
Division name
Research center for charged particle therapy
Zip code
Address
4-9-1 Anagawa, Inage-ku, Chiba 263-8555, Japan
TEL
043-206-3350
Homepage URL
h_tsuji@nirs.go.jp
Sponsor or person
Institute
National Institute of Radiological Sciences, Network congress of charged particle therapy
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 06 | Month | 10 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004624
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
