UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012109 |
|---|---|
| Receipt number | R000014156 |
| Scientific Title | Clinical trial to evaluate safety and efficacy of radiofrequency ablation for malignant tumors located outside the liver |
| Date of disclosure of the study information | 2013/10/23 |
| Last modified on | 2017/10/26 09:42:26 |
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Basic information
Public title
Clinical trial to evaluate safety and efficacy of radiofrequency ablation for malignant tumors located outside the liver
Acronym
Clinical trial to evaluate safety and efficacy of radiofrequency ablation for malignant tumors located outside the liver
Scientific Title
Clinical trial to evaluate safety and efficacy of radiofrequency ablation for malignant tumors located outside the liver
Scientific Title:Acronym
Clinical trial to evaluate safety and efficacy of radiofrequency ablation for malignant tumors located outside the liver
Region
| Japan |
Condition
Condition
malignant tumors which have lesions located outside the liver
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Endocrinology and Metabolism | Hematology and clinical oncology | Nephrology |
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Chest surgery |
| Endocrine surgery | Breast surgery | Obstetrics and Gynecology |
| Pediatrics | Dermatology | Oto-rhino-laryngology |
| Orthopedics | Urology | Radiology |
| Oral surgery | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of radiofrequency ablation for malignant tumors located outside the liver
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Overall survival
Frequency of adverse events
Key secondary outcomes
Local tumor progression rate
Recurrence rate
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
| Maneuver |
Interventions/Control_1
To perform radiofrequency ablation for malignant tumors located outside the liver
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Tumors which are eligible for radiofrequency ablation in a solid organ or others
2)Ineligible for surgical resection or patient refusal for surgery
3)A single tumor 6 cm in diameter or three or fewer tumors all 3 cm or less in diameter
4)There are no tumors ineligible for radiofrequency ablation or, if any, tumors are much less in volume compared with those treated by radiofrequency ablation and would not determine the prognosis
5)In cases in which tumors are very likely to recur, or in which some malignant tissue is likely to remain unablated, it is necessary that patients should achieve stable disease or better response to chemotherapy or that at least some standardized regimens of chemotherapy is feasible
6)Patients who give written informed consent prior to the study
Key exclusion criteria
1)Tumors not visualized by ultrasonography/not accessible percutaneously
2)Patients in whom ablation of the tumors is highly likely to cause damage of other organs or tissues
3)Patients with marked bleeding tendency
4)Patients with The American Society of Anesthesiologists physical state (ASA PS) 3 or more
5)Patients who cannot follow instructions because of dementia
6)Patients in whom therapeutic efficacy cannot be evaluated with contrast-enhanced CT scan or others, because of renal dysfunction or adverse reactions to contrast agents
7)Patients in whom effective measures, such as transfusion and others, cannot be used for adverse events because of religious reasons or others
8)Patients considered to be ineligible for participation in the study by the investigator or subinvestigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuichiro Shiina |
Organization
Juntendo University Graduate School of Medicine
Division name
Division of Diagnostic Imaging and Minimally Invasive Therapy
Zip code
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
sshiina-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuichiro Shiina |
Organization
Juntendo University Graduate School of Medicine
Division name
Division of Diagnostic Imaging and Minimally Invasive Therapy
Zip code
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
sshiina-tky@umin.ac.jp
Sponsor or person
Institute
Division of Diagnostic Imaging and Minimally Invasive Therapy, Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Diagnostic Imaging and Minimally Invasive Therapy, Juntendo University Graduate School of Medicine
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
順天堂大学医学部附属順天堂医院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 23 | 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 | 10 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 01 | 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 | 10 | Month | 23 | Day |
Last modified on
| 2017 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014156
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| Registered date | File name |
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