UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002132 |
|---|---|
| Receipt number | R000002605 |
| Scientific Title | Phase I/II clinical trial of comparison between carbon-ion therapy and proton therapy for primary tumors |
| Date of disclosure of the study information | 2009/06/29 |
| Last modified on | 2011/07/02 23:56:53 |
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Basic information
Public title
Phase I/II clinical trial of comparison between carbon-ion therapy and proton therapy for primary tumors
Acronym
Phase I/II clinical trial of comparison between carbon-ion therapy and proton therapy for primary tumors
Scientific Title
Phase I/II clinical trial of comparison between carbon-ion therapy and proton therapy for primary tumors
Scientific Title:Acronym
Phase I/II clinical trial of comparison between carbon-ion therapy and proton therapy for primary tumors
Region
| Japan |
Condition
Condition
primary malignant tumors
Classification by specialty
| Hepato-biliary-pancreatic medicine | Pneumology | Hepato-biliary-pancreatic surgery |
| Chest surgery | Oto-rhino-laryngology | Orthopedics |
| Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare carbon-ion therapy and proton therapy for primary tumors in terms of safety and efficacy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Local control rate
Key secondary outcomes
Late adverse effects
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Carbon-ion therapy
Interventions/Control_2
Proton therapy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Primary tumors of the head and neck, lung, liver, and bone and soft tissue eligible for the inclusion criteria and ineligible for the exclusion criteria of Hyogo Ion Beam Medical Center
2) 20 years old or older
3) Can be treated by either carbon-ion therapy or proton therapy
4) Expected to survive for 6 months or greater
5) Written informed consent
Key exclusion criteria
1) Pregnant, possible to be pregnant, or lactating
2) Judged to have difficulty being enrolled in the trial due to mental disorder
3) Can not meet the dose constraint of organs at risk in treatment planning
Target sample size
396
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masao Murakami |
Organization
Hyogo Ion Beam Medical Center
Division name
Department of Radiology
Zip code
Address
1-2-1 Kouto, Shingu-cho, Tatsuno, Hyogo
TEL
0791-58-1315
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Demizu |
Organization
Hyogo Ion Beam Medical Center
Division name
Department of Radiology
Zip code
Address
1-2-1 Kouto, Shingu-cho, Tatsuno, Hyogo
TEL
0791-58-1315
Homepage URL
y.demizu@hibmc.shingu.hyogo.jp
Sponsor or person
Institute
Department of Radiology, Hyogo Ion Beam Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 06 | Month | 29 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 06 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 06 | Month | 28 | Day |
Last modified on
| 2011 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002605
