UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054072 |
|---|---|
| Receipt number | R000061740 |
| Scientific Title | Combination therapy with cryoablation and radiofrequency ablation for lung cancer |
| Date of disclosure of the study information | 2024/04/05 |
| Last modified on | 2024/04/05 12:12:43 |
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Basic information
Public title
Combination therapy with cryoablation and radiofrequency ablation for lung cancer
Acronym
Combination therapy with cryoablation and radiofrequency ablation for lung cancer
Scientific Title
Combination therapy with cryoablation and radiofrequency ablation for lung cancer
Scientific Title:Acronym
Combination therapy with cryoablation and radiofrequency ablation for lung cancer
Region
| Japan |
Condition
Condition
Primary lung cancer and metastatic lung cancer
Classification by specialty
| Pneumology | Chest surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Complication and local control rate with combination therapy with cryoablation and radiofrequency ablation for lung cancer comparing with single modality therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Local control rate and survival rate more than 3 years after the treatment
Key secondary outcomes
Short- and long-term complications after treatment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
For lung cancer, after cryoablation, the cryoablation probe is replaced by radiofrequency probe, followed by cryoablation.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Lung cancer larger than 2 cm.
2. Even for lung cancer less than 2 cm, metastatic lung cancer, primary lung cancer with high FDG-uptake on PET, and predicted resistance for freezing or heating.
3. Patient strongly requested the combination therapy with cryoablation and radiofrequency ablation.
Key exclusion criteria
1. Severe pulmonary failure.
2. Life expectancy is predicted to be less than 6 months.
3. Active interstitial pneumonia.
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 617, Kashiwa-city, Chiba prefecture
TEL
+81471451111
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 617, Kashiwa city, Chiba prefecture
TEL
0471451111
Homepage URL
hnomori@qk9.so-net.ne.jp
Sponsor or person
Institute
Kashiwa Kousei General Hospital
Institute
Department
Personal name
Hiroaki Nomori
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 prefecture
Tel
+81471451111
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
柏厚生総合病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 05 | 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
| 2024 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 05 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2034 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2034 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2035 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2035 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 05 | Day |
Last modified on
| 2024 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061740
