UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026419 |
|---|---|
| Receipt number | R000030322 |
| Scientific Title | Phase 2 trial of Proton Beam Therapy for malignancy pediatric tumor. |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2024/01/05 10:56:52 |
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Basic information
Public title
Phase 2 trial of Proton Beam Therapy for malignancy pediatric tumor.
Acronym
PBT for malignancy pediatric tumor.
Scientific Title
Phase 2 trial of Proton Beam Therapy for malignancy pediatric tumor.
Scientific Title:Acronym
PBT for malignancy pediatric tumor.
Region
| Japan |
Condition
Condition
Malignant pediatric tumor below the age of 20.
Classification by specialty
| Pediatrics | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of pediatric tumor after proton beam therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Late toxicity, acute toxicity, secondary cancer
Key secondary outcomes
Overall survival, Progression free survival, Local control rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Proton beam therapy
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
| 20 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Having therapeutic adaptation of radiotherapy.
Under the age of 20.
Having malignant tumor.
Written informed consent.
Key exclusion criteria
In pregnancy.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyuki Sakurai |
Organization
University of Tsukuba Hospital
Division name
Radiation Oncology
Zip code
Address
Amakubo 2-1-1, Tsukuba city, Ibaraki, Japan
TEL
0298537100
proton_therapy@pmrc.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masashi Mizumoto |
Organization
University of Tsukuba Hospital
Division name
Radiation Oncology
Zip code
Address
Amakubo 2-1-1, Tsukuba city, Ibaraki, Japan
TEL
029-853-7100
Homepage URL
proton_therapy@pmrc.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2032 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2032 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2032 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2032 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 06 | Day |
Last modified on
| 2024 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030322
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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