UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trial to evaluate safety and efficacy of radiofrequency ablation for malignant tumors located outside the liver
Title of the study (Brief title)	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	Shuichiro Shiina
Organization	Juntendo University Graduate School of Medicine
Division name	Division of Diagnostic Imaging and Minimally Invasive Therapy
Address	2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Email	sshiina-tky@umin.ac.jp

Public contact
Name of contact person	Shuichiro Shiina
Organization	Juntendo University Graduate School of Medicine
Division name	Division of Diagnostic Imaging and Minimally Invasive Therapy
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 10 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000014156