UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037215 |
|---|---|
| Receipt number | 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 17:07:15 |
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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
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
hnomori@qk9.so-net.ne.jp
Sponsor or person
Institute
Kashiwa Kousei General Hospital, Thoracic Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042431
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
