UMIN-CTR Clinical Trial

Basic information
Public title	CT guided cryoablation for malignant lung tumor
Acronym	Cryoablation for malignant lung tumor
Scientific Title	CT guided cryoablation for malignant lung tumor
Scientific Title:Acronym	Cryoablation for malignant lung tumor
Region	Japan

Condition
Condition	primary lung cancer, metastatic lung cancer
Classification by specialty	Pneumology Hematology and clinical oncology Chest surgery Radiology Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Effectiveness and complications of cryoablation using liquid nitrogen for primary or metastatic lung cancers are examined.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	5 years-local control rate
Key secondary outcomes	Complication, 5 years-recurrence-free 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	Maneuver
Interventions/Control_1	For patients with primary or metastatic lung cancers less than 3 cm, the followings are explained: 1.Standard treatment is surgery if resectable, 2. As non-surgical treatment, the radiation is the first choice, 3. As another non-surgical treatment, the cryoablation is also available. When the patient request the cryoablation, it will be done.
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	10 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Stage I primary lung cancer less than 3 cm. Metastatic lung cancer less than 3 cm. Patients request cryoablation.
Key exclusion criteria	Severe pulmonary dysfunction
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Hiroaki Middle name Last name Nomori
Organization	kashiwa kousei General Hospital
Division name	Department of thoracic surgery
Zip code	277-8551
Address	Shikoda 612, Kashiwa city, Chiba
TEL	0471-45-1111
Email	hnomori@qk9.so-net.ne.jp

Public contact
Name of contact person	1st name Hiroaki Middle name Last name Nomori
Organization	kashiwa kousei General Hospital
Division name	Department of thoracic surgery
Zip code	277-8551
Address	Shikoda 612, Kashiwa city, Chiba
TEL	0471-45-1111
Homepage URL
Email	hnomori@qk9.so-net.ne.jp

Sponsor
Institute	Department of thoracic surgery, Kashiwa Kousei General Hospital
Institute
Department

Funding Source
Organization	kashiwa Kousei General Hospital
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	Kashiwa Kousei General Hospital
Address	Shikoda 617, Kashiwa city, Chiba
Tel	0471-45-1111
Email	hnomori@qk9.so-net.ne.jp

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	2019 Year 06 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	Open public recruiting
Date of protocol fixation	2019 Year 02 Month 15 Day
Date of IRB	2019 Year 02 Month 27 Day
Anticipated trial start date	2019 Year 06 Month 28 Day
Last follow-up date	2029 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 06 Month 30 Day
Last modified on	2019 Year 06 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042430