UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Protocol for BNCT against recurrent head and neck tumors(two)
Title of the study (Brief title)	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	Junichi Hiratsuka
Organization	Kawasaki Medical School
Division name	Radiation Oncology
Address	577 Matsushima Kurashiki City
TEL	086-462-1111
Email	hiratuka@med.kawasaki-m.ac.jp

Public contact
Name of contact person	Remi Kawanishi
Organization	Kawasaki Medical School
Division name	Devision of Research Support
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 02 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000015350