UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027541 |
|---|---|
| Receipt number | R000031573 |
| Scientific Title | Clinical trial of boron neutron capture therapy utilizing research reactor for skin malignant tumors |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2020/03/03 11:57:57 |
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Basic information
Public title
Clinical trial of boron neutron capture therapy utilizing research reactor for skin malignant tumors
Acronym
Clinical trial of skin malignancy BNCT
Scientific Title
Clinical trial of boron neutron capture therapy utilizing research reactor for skin malignant tumors
Scientific Title:Acronym
Clinical trial of skin malignancy BNCT
Region
| Japan |
Condition
Condition
skin malignant tumors
Classification by specialty
| Dermatology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
effectiveness
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
tumor response rate and adverse events 6 months after BNCT
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
BPA is administrated as boron carrier and reactor is utilized as neutron source.
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
| 16 | years-old | <= |
Age-upper limit
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.skin tumors that have relapsed after conventional therapies
2.inoperable skin malignant tumors
3.Without distant metastases
4.PS: less than 2
5.Consent to perform BNCT
6.With the approval of the Medical Ethics Committee
7.Japanese at the age of 16 to 89
Key exclusion criteria
1.with severe complications or double cancers
2.first therapy induced more than Grade 3 side effect
3.medically or socially unacceptable patients
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichi Hiratsuka |
Organization
Kawasaki Medical School
Division name
Radiation Oncology
Zip code
Address
577 Matsushima, Kurashiki city
TEL
086-462-1111
hiratuka@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kawanishi |
Organization
Kawasaki Medical School
Division name
Division of Reseach Support
Zip code
Address
577 Matsushima, Kurashiki city
TEL
086-462-1111
Homepage URL
kenkyu-idai@med.kawasaki-m.ac.jp
Sponsor or person
Institute
kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Japanese Government
Organization
Division
Category of Funding Organization
Japanese Governmental office
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 | 08 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 30 | Day |
Last modified on
| 2020 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031573
