UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015509 |
|---|---|
| Receipt number | 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 09:25:53 |
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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
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
satorushintani@gmail.com
Public contact
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
shintaniclinic@gmail.com
Sponsor or person
Institute
Tokyo Ginza Shintani Clinic, Dental, Oral
and Maxillofacial Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018021
