UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009969 |
|---|---|
| Receipt number | R000011664 |
| Scientific Title | The research of establishment of therapeutic method and safety in High-Intensity Focused Ultrasound (HIFU) therapy for unresectable pancreatic cancer |
| Date of disclosure of the study information | 2013/02/05 |
| Last modified on | 2017/02/08 16:53:03 |
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Basic information
Public title
The research of establishment of therapeutic method and safety in High-Intensity Focused Ultrasound (HIFU) therapy for unresectable pancreatic cancer
Acronym
The research of HIFU therapy for unresectable pancreas cancer
Scientific Title
The research of establishment of therapeutic method and safety in High-Intensity Focused Ultrasound (HIFU) therapy for unresectable pancreatic cancer
Scientific Title:Acronym
The research of HIFU therapy for unresectable pancreas cancer
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the safety in HIFU therapy for unresectable pancreatic cancer and establish HIFU therapeutic method for pancreatic cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
the safety
Key secondary outcomes
the effect and usefulness of therapy
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
HIFU equipment:FEP-BY02(China Medical Tecnologies Co.)
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
* age >20 years old
* WBC > 2000
Plt >5
Cre > 3.0 mg/dl
*Normal EKG
*PS: 0~3
*Survival time > 4 weeks
Key exclusion criteria
*The patients with other malignancy
*Pregnancy case
*Obstructive Jaundice
*The patients with severe heart and brain disease
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Sofuni |
Organization
Tokyo Medical University
Division name
Gastroenterology and Hapatology
Zip code
Address
6-7-1 Nishishinjuku Shinjuku-ku 160-0023 Tokyo Japan
TEL
03-3342-6111
naika4@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Sofuni |
Organization
Tokyo Medical University
Division name
Gastroenterology and hepatology
Zip code
Address
6-7-1 Nisishinjuku Shinjyuku-ku 160-0023
TEL
03-3342-6111
Homepage URL
a-sofuni@amy.hi-ho.ne.jp
Sponsor or person
Institute
Tokyo Medical University
Dept.of Gastroenterology and hepatology
Institute
Department
Personal name
Funding Source
Organization
Cancer therapy research group of Tokyo Medical University
Organization
Division
Category of Funding Organization
Other
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
東京医科大学 消化器内科
Tokyo Medical University Dept. of Gastroenterology and hapatology
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 02 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 05 | 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
| 2013 | Year | 02 | Month | 05 | Day |
Last modified on
| 2017 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011664
