UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039288 |
|---|---|
| Receipt number | 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 17:00:39 |
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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
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
mkamei@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044810
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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