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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018573
Receipt No. R000021496
Scientific Title Prospective study of safety and efficacy of additional cryoablation after radiation therapy for malignant lung tumors
Date of disclosure of the study information 2015/08/06
Last modified on 2019/10/02

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Basic information
Public title Prospective study of safety and efficacy of additional cryoablation after radiation therapy for malignant lung tumors
Acronym Prospective study of cryoablation after radiation therapy for malignant lung tumors
Scientific Title Prospective study of safety and efficacy of additional cryoablation after radiation therapy for malignant lung tumors
Scientific Title:Acronym Prospective study of cryoablation after radiation therapy for malignant lung tumors
Region
Japan

Condition
Condition primary lung cancer, metastatic lung cancer
Classification by specialty
Pneumology Chest surgery Operative medicine
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.Study duration is from July 2015 to March 2020.
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
15 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Malignant lung tumors larger than 2cm.
Key exclusion criteria Patients who are not torelable for radiotherapy and cryoablation therapy.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hiroaki
Middle name
Last name Nomori
Organization Kameda Medical Center
Division name Thoracic Surgery
Zip code 296-8602
Address 929 Higashi-cho, Komogawa city, Chiba
TEL 04-7092-2211
Email hnomori@qk9.so-net.ne.jp

Public contact
Name of contact person
1st name Harue
Middle name
Last name Tachibana
Organization Kameda Medical Center
Division name Review Board of Clinical Research
Zip code 296-8602
Address 929 Higashi-cho, Kamogawa city, Chiba
TEL 04-7092-2211
Homepage URL
Email clinical_research@kameda.jp

Sponsor
Institute Kameda Medical Center
Institute
Department

Funding Source
Organization Kameda Medical Center
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 Kameda Medical Center
Address HIgashi-cho 929, Kamogawa city, Chiba perfecture
Tel 0470-92-2211
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
2015 Year 08 Month 06 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
2015 Year 06 Month 17 Day
Date of IRB
2015 Year 08 Month 01 Day
Anticipated trial start date
2015 Year 08 Month 06 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
2023 Year 03 Month 31 Day
Date trial data considered complete
2023 Year 03 Month 31 Day
Date analysis concluded
2025 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 08 Month 06 Day
Last modified on
2019 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021496

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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