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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023170
Receipt No. R000026233
Scientific Title Phase II trial of Proton Beam Therapy for pediatric and Adolescent and Young Adult (AYA) tumor, except for solid malignancy pediatric tumor.
Date of disclosure of the study information 2016/07/25
Last modified on 2018/07/17

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Basic information
Public title Phase II trial of Proton Beam Therapy for pediatric and Adolescent and Young Adult (AYA) tumor, except for solid malignancy pediatric tumor.
Acronym PBT for pediatric and Adolescent and Young Adult (AYA) tumor.
Scientific Title Phase II trial of Proton Beam Therapy for pediatric and Adolescent and Young Adult (AYA) tumor, except for solid malignancy pediatric tumor.
Scientific Title:Acronym PBT for pediatric and Adolescent and Young Adult (AYA) tumor.
Region
Japan

Condition
Condition Pediatric and Adolescent and Young Adult (AYA) tumor, except for solid malignancy pediatric tumor.
Classification by specialty
Pediatrics Radiology Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and effectiveness of proton beam therapy for pediatric and adolescent and Young Adult (AYA) tumor.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Acute toxicity, Late toxicity, secondary cancer.
Key secondary outcomes Overall survival, Local control rate, Progression free survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Proton beam therapy for pediatric tumor
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
1 years-old <=
Age-upper limit
40 years-old >
Gender Male and Female
Key inclusion criteria Having indication for treatment of Radiotherapy.
Key exclusion criteria Not having indication for treatment of Radiotherapy.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideyuki Sakurai
Organization Department of Radiation Oncology,
University of Tsukuba
Division name Radiation Oncology
Zip code
Address Amakubo 2-1-1, Tsukuba, Ibaraki
TEL 029-853-7100
Email proton_therapy@pmrc.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masashi Mizumoto
Organization Department of Radiation Oncology, University of Tsukuba
Division name Department of Radiation Oncology
Zip code
Address Amakubo 2-1-1, Tsukuba, Ibaraki
TEL 029-853-7107
Homepage URL
Email mizumoto1717@hotmail.com

Sponsor
Institute University of Tsukuba
Institute
Department

Funding Source
Organization University of Tsukuba Hospital
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
Email

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
2016 Year 07 Month 25 Day

Related information
URL releasing protocol http://www.hosp.tsukuba.ac.jp/clintrial/TCReDO.html
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 07 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 01 Day
Last follow-up date
2026 Year 07 Month 01 Day
Date of closure to data entry
2026 Year 07 Month 01 Day
Date trial data considered complete
2026 Year 07 Month 01 Day
Date analysis concluded
2030 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2016 Year 07 Month 14 Day
Last modified on
2018 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026233

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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