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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000015509
Receipt No. R000018021
Scientific Title Clinical trials of hyperthermia using new device for patient with recurrence and/or advanced oral malignancy resistant to standard therapies.
Date of disclosure of the study information 2014/11/01
Last modified on 2016/04/23

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Basic information
Public title Clinical trials of hyperthermia using new device for patient with recurrence and/or advanced oral malignancy resistant to standard therapies.
Acronym Clinical trials of hyperthermia using new device for oral malignancy
Scientific Title Clinical trials of hyperthermia using new device for patient with recurrence and/or advanced oral malignancy resistant to standard therapies.
Scientific Title:Acronym Clinical trials of hyperthermia using new device for oral malignancy
Region
Japan

Condition
Condition Oral malignancy
Classification by specialty
Oral surgery Dental medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Clinical trials of hyperthermia using new device for patient with recurrence and/or advanced oral malignancy resistant to standard therapies.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Overall survival time
Ungot worse survival time
Diagnostic imaging evaluation
Observation of tumor
Key secondary outcomes Adverse event

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
Device,equipment
Interventions/Control_1 Hyperthermia
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Oral malignancy
Survival expectation>=3 months
Performance status: 0-2
Not participate in other trials
Not critical organ injury, a bleeding tendency, and infection
Participating consent by a free intention
Key exclusion criteria Serious clinical symptoms
A life support system, a pacemaker wearing person
Psychiatric disorder
Immunodeficiency disease
Pregnant woman
Any other patients whom the investigator has determined to be unsuitable
Target sample size 5

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Satoru Shintani
Organization Tokyo Ginza Shintani Clinic, Dental, Oral
and Maxillofacial Surgery

Division name Director
Zip code
Address Ginza-Daishin Bill 5F, 1-8-14 Ginza, Chuo-ku , Tokyo Japan
TEL 03-3538-8148
Email satorushintani@gmail.com

Public contact
1st name of contact person
1st name
Middle name
Last name Satoru Shintani
Organization Tokyo Ginza Shintani Clinic, Dental, Oral
Division name Director
Zip code
Address Ginza-Daishin Bill 5F, 1-8-14 Ginza, Chuo-ku , Tokyo Japan
TEL 03-3538-8148
Homepage URL
Email shintaniclinic@gmail.com

Sponsor
Institute Tokyo Ginza Shintani Clinic, Dental, Oral
and Maxillofacial Surgery


Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 11 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
2014 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date
2014 Year 12 Month 12 Day
Last follow-up date
2016 Year 04 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 10 Month 23 Day
Last modified on
2016 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018021

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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