UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005225 |
|---|---|
| Receipt number | R000006194 |
| Scientific Title | Clinical investigation of heavy ion therapy system using scanning irradiation |
| Date of disclosure of the study information | 2011/03/15 |
| Last modified on | 2016/11/01 14:13:16 |
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Basic information
Public title
Clinical investigation of heavy ion therapy system using scanning irradiation
Acronym
Clinical investigation of heavy ion scanning system
Scientific Title
Clinical investigation of heavy ion therapy system using scanning irradiation
Scientific Title:Acronym
Clinical investigation of heavy ion scanning system
Region
| Japan |
Condition
Condition
Malignant tumor
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate safety and stability of new treatment system using heavy particle scanning irradiation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Acute radiation toxicity
Key secondary outcomes
PET/CT imaging of autoactivation due to heavy particle irradiation
Initial response of treated lesion
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
New treatment system using heavy particle scanning irradiation
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 and Female
Key inclusion criteria
1)Patient with malignant tumor at the head and neck or pelvic region, for which heavy ion therapy with passive modulation can be applied
2)Heavy particle therapy can be applied without respiratory gating system
3)Without other severe medical problem and performance status of 0 or 1
4)Written informed consent
Key exclusion criteria
1)Previous irradiation to the same site of the tumor
2)Expected prognosis within 6 months
3)Performance status more than or equal to 2
4)Active infection at the same site of the tumor
5)Other medical reasons for exclusion
Target sample size
15
Research contact person
Name of lead principal investigator
| 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 Japan
TEL
043-206-3350
tsuji.hiroshi@qst.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 Japan
TEL
043-206-3350
Homepage URL
h_tsuji@nirs.go.jp
Sponsor or person
Institute
National Institute of Radiological Sciences
Institute
Department
Personal name
Funding Source
Organization
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 15 | 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
Completed
Date of protocol fixation
| 2011 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 03 | Month | 09 | 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=R000006194
| 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 |
