UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and Efficacy of Percutaneous Cryoablation for Thoracic Malignancies
Title of the study (Brief title)	Percutaneous Cryoablation for Thoracic Malignancies
Region	Japan

Condition
Condition	Primary lung cancer, metastatic lung cancer, mediastinal tumor, chest wall tumor
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safty and efficacy of cryoablation for thoracic malignancies
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Primary outcomes are treatment-related mortality, morbidity, local control and overall survival.
Key secondary outcomes

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	Cryoablation for thoracic malignancies
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	16 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	1)Diagnosed as having thoracic malignancies 2)Medically inoperable 3)performance status 0-2 4)16 - 90 years old 5)projected life expectancy of greater than 6 months 6)consent obtained from the attending physician who treats primary tumor (only for patients with metastatic lung tumor) 7)possible to visit the clinic every 3 months after treatment 8)provision of written informed consent
Key exclusion criteria	1)abnormal coagulability 2)active bleeding 3)active infection 4)untreatable brain tumor 5)general anesthesia 6)impossible to communicate 7)prognosis limiting lesion out of thorax 8)more than 10 tumors 9)judged as inadequate by physician
Target sample size	200

Research contact person
Name of lead principal investigator	Seishi Nakatsuka
Organization	School of Medicine, Keio University
Division name	Department of Diagnostic Radiology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-3353-1211
Email	nakatsuk@a2.keio.jp

Public contact
Name of contact person	Takashi Ohtsuka
Organization	School of Medicine, Keio University
Division name	Division of General Thoracic Surgery, Department of Surgery
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL	03-5363-3806
Homepage URL
Email	ohtsuka@a3.keio.jp

Sponsor
Institute	School of Medicine, Keio University
Institute
Department

Funding Source
Organization	School of Medicine, Keio University
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

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 08 Month 11 Day
Anticipated trial start date	2014 Year 10 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	2014 Year 08 Month 29 Day
Last modified on	2018 Year 10 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017442