UMIN-CTR Clinical Trial

Basic information
Public title	Safety and Clinical Outcomes of Percutaneous Cryoablation for Musculoskeletal Tumor: a Phase-II Clinical Study
Acronym	Percutaneous Cryoablation for Musculoskeletal Tumor
Scientific Title	Safety and Clinical Outcomes of Percutaneous Cryoablation for Musculoskeletal Tumor: a Phase-II Clinical Study
Scientific Title:Acronym	Percutaneous Cryoablation for Musculoskeletal Tumor
Region	Japan

Condition
Condition	musculoskeletal tumor
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This prospective study is undertaken to evaluate the safety and outcomes of cryoablation in patients with musculoskeletal tumors.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	The primary endpoint is safety that is evaluated by Common Terminology Criteria for Adverse Events (CTCAE ver 4.0).
Key secondary outcomes	The secondary endpoints are changes in visual analogue scale (VAS) score, tumor response, and survival.

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 Maneuver
Interventions/Control_1	All procedures are performed under real-time CT fluoroscopic guidance. After the patient is placed on the CT couch in the supine, prone, or lateral position, cryoprobes are consecutively placed with 1-2cm interval in the tumor based on the tumor size and location directly or through an bone biopsy needle.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Inclusion criteria of this study are as follows: musculoskeletal tumor measuring 5.0 cm or less without regard to pain; age of 20 years or more; Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2 or 3; adequate main organ function; and a life expectancy of 1 month or longer. Patients have either single tumor or multiple tumors.
Key exclusion criteria	Exclusion criteria is an abnormal coagulability as defined by platelet count of less than 50,000/mm3, and an international normalized ratio (INR) of greater than 1.5.
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Koichiro Yamakado
Organization	Mie University School of Medicine
Division name	Department of Radiology
Zip code
Address	2-174 Edobashi, Tsu city, Mie Prefecture, Japan
TEL	+81-59-231-5029
Email

Public contact
1st name of contact person	1st name Middle name Last name Koichiro Yamakado
Organization	Mie University School of Medicine
Division name	Department of Radiology
Zip code
Address	2-174 Edobashi, Tsu city, Mie Prefecture, Japan
TEL	+81-59-231-5029
Homepage URL
Email

Sponsor
Institute	Department of Radiology, Mie University School of Medicine
Institute
Department

Funding Source
Organization	Department of Radiology, Mie University 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

Other administrative information
Date of disclosure of the study information	2013 Year 01 Month 30 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	Completed
Date of protocol fixation	2012 Year 10 Month 10 Day
Date of IRB	2013 Year 01 Month 29 Day
Anticipated trial start date	2013 Year 01 Month 30 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 01 Month 30 Day
Last modified on	2019 Year 03 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011601