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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039288
Receipt No. R000044810
Scientific Title Space-modulated proton therapy with polyglycolic acid spacer in pediatric tumor
Date of disclosure of the study information 2020/01/29
Last modified on 2020/01/28

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Basic information
Public title Space-modulated proton therapy with polyglycolic acid spacer in pediatric tumor
Acronym Space-modulated proton therapy with polyglycolic acid spacer
Scientific Title Space-modulated proton therapy with polyglycolic acid spacer in pediatric tumor
Scientific Title:Acronym Space-modulated proton therapy with polyglycolic acid spacer
Region
Japan

Condition
Condition Pediatric solid malignant tumo
Classification by specialty
Hematology and clinical oncology Surgery in general Pediatrics
Radiology Child
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This trial evaluates the safety of the utilization of proton beam therapy with polyglycolic acid spacer replacement for pediatric solid tumor.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Frequencies of non-hematological toxicity greater than grade 3 by CTCAE criteria
Key secondary outcomes 1) Proton beam treatment completion rate
2) Spacer withdrawal rate
3) Dose volume distribution
4) Change of extension of treatment period


Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Spacer replacement
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 months-old <=
Age-upper limit
228 months-old >=
Gender Male and Female
Key inclusion criteria 1) Patients diagnosed with pediatric malignant solid tumor in abdominal or pelvic cavity.
2) The regions are limited and controlled.
3) Patients can be surgically replaced with PGA-spacer between the tumor and normal organ.
4) Patient age 30days or over 30 days and under 20 years.
5) Patients who can receive particle beam irradiation after PGA-spacer replacement.
6) Patients should obtain written consent if they are 16 years old or older. If they are under 16 years old, their proxies could do that for participation in this study.
Key exclusion criteria 1) Patients with active and refractory infection at their irradiated site
2) Patients who have digestive ulcer at the site of irradiation.
3) Patients with severe liver or kidney disfunction
4) Patients who are pregnant, breast-feeding, or cannot agree with contraception during this study.
5) Patients who have PAG allergy.
6) Patients who are judged inappropriate by the researcher in this study.
Target sample size 3

Research contact person
Name of lead principal investigator
1st name Michi
Middle name
Last name KAMEI
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Neonatology and Pediatrics
Zip code 467-8601
Address 1 Kawasumi, Mizuho-cyo, Mizuho-ku, Nagoya City, Aichi 467-8601, Japan
TEL 052-853-8246
Email mkamei@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name Michi
Middle name
Last name KAMEI
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Neonatology and Pediatrics
Zip code 467-8601
Address 1 Kawasumi, Mizuho-cyo, Mizuho-ku, Nagoya City, Aichi 467-8601, Japan
TEL 052-853-8246
Homepage URL
Email mkamei@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development,
National Research and Development Corporation
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Clinical research manager center, Nagoya City University Hospital
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku Nagoya 467-8601, Japan
Tel 052-858-7215
Email clinical_research@med.nagoya-cu.ac.jp

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
2020 Year 01 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 Open public recruiting
Date of protocol fixation
2019 Year 10 Month 15 Day
Date of IRB
2019 Year 10 Month 24 Day
Anticipated trial start date
2019 Year 12 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 01 Month 28 Day
Last modified on
2020 Year 01 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044810

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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