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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037215
Receipt No. R000042431
Scientific Title Study of safety and efficacy of additional cryoablation after radiation therapy for malignant lung tumors
Date of disclosure of the study information 2019/06/30
Last modified on 2019/06/30

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Basic information
Public title Radioation therapy followed by cryoablation for malignant lung tumors
Acronym Combined treatment by radiation therapy and cryoablation for malignant lung tumros
Scientific Title Study of safety and efficacy of additional cryoablation after radiation therapy for malignant lung tumors
Scientific Title:Acronym Combined treatment by radiation therapy and cryoablation for malignant lung tumros
Region
Japan

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

Objectives
Narrative objectives1 The safety and efficacy of cryoablation after radiotherapy for malignant lung tumors larger than 2 cm in size are prospectively studied.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Side effect and local control rate by cryoablation after radiotherapy for malignant lung tumors
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 is conducted after radiotherapy for malignant lung tumors larger than 2cm.
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 Malignant lung tumors larger than 1.8cm.
Key exclusion criteria Patients who are not torelable for radiotherapy and cryoablation therapy.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Hiroaki
Middle name
Last name Nomori
Organization Kashiwa Kousei General Hospital
Division name Thoracic Surgery
Zip code 277-8551
Address Shikoda 617, 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 Thoracic Surgery
Zip code 277-8551
Address Shikoda 617, Kashiwa-city, Chiba
TEL 0471-45-1111
Homepage URL
Email hnomori@qk9.so-net.ne.jp

Sponsor
Institute Kashiwa Kousei General Hospital, Thoracic Surgery
Institute
Department

Funding Source
Organization Kashiwa Kousei General Hospital, Thoracic Surgery
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 28 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=R000042431

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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