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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012109
Receipt No. 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

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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 Obsterics 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
Email 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
Email sshiina-tky@umin.ac.jp

Sponsor
Institute Division of Diagnostic Imaging and Minimally Invasive Therapy, Juntendo University Graduate School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014156

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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