UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018573 |
|---|---|
| Receipt number | 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 11:27:33 |
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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
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
clinical_research@kameda.jp
Sponsor or person
Institute
Kameda Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021496
