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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013163
Receipt No. R000015350
Scientific Title Protocol for BNCT against recurrent head and neck tumors(two)
Date of disclosure of the study information 2014/03/20
Last modified on 2017/02/21

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Basic information
Public title Protocol for BNCT against recurrent head and neck tumors(two)
Acronym BNCT against head and neck tumors
Scientific Title Protocol for BNCT against recurrent head and neck tumors(two)
Scientific Title:Acronym BNCT against head and neck tumors
Region
Japan

Condition
Condition recurrent head and neck tumors
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 establishment of protocol
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes safty
Key secondary outcomes effectiveness

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
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 boron carrier (drug) and irradiation machine
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

Not applicable
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria patients who cannot receive standard therapies, and will have severe and untolerable damades following standard therapies.
Key exclusion criteria general condition:poor.
patients who have developed other kinds of cancers or distant metastases.
Target sample size 20

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
Email hiratuka@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Remi Kawanishi
Organization Kawasaki Medical School
Division name Devision of Research Support
Zip code
Address 577 Matsushima Kurashiki City
TEL 086-462-1111
Homepage URL
Email kenkyu-idai@med.kawasaki-m.ac.jp

Sponsor
Institute Junichi Hiratsuka
Institute
Department

Funding Source
Organization MEXT(Japan)
Organization
Division
Category of Funding Organization
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
2014 Year 03 Month 20 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
2014 Year 02 Month 14 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 02 Month 14 Day
Last modified on
2017 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015350

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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