UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027543 |
|---|---|
| Receipt number | R000030073 |
| Scientific Title | Phase one/ two clinical trial of boron neutro capture therapy for head and neck malignancies |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2020/03/03 11:56:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Phase one/ two clinical trial of boron neutro capture therapy for head and neck malignancies
Acronym
Clinical trial of BNCT for head and neck malignancies
Scientific Title
Phase one/ two clinical trial of boron neutro capture therapy for head and neck malignancies
Scientific Title:Acronym
Clinical trial of BNCT for head and neck malignancies
Region
| Japan |
Condition
Condition
Head and Neck cancers
Classification by specialty
| Nephrology | Oto-rhino-laryngology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
tumor response
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
tumor response
Key secondary outcomes
safty
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 research 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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.With head and neck tumors that have relapsed after conventional therapies
2.Without distant metastases
3.PS is less than 2
4.Tumor to Normal tissue boron ratio is more than 2.5 using 18F-BPA-PET
5.Consent to perform BNCT
6.With the approval of the Medical Ethics Committee
Key exclusion criteria
1.with severe complications
2.medically or socially unacceptable patients
3.with pace maker
Target sample size
15
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 Research Sopport
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 | 02 | Month | 17 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | 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
| 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=R000030073
