UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050454 |
|---|---|
| Receipt number | R000057459 |
| Scientific Title | Radio-frequency-ablation for lung cancer under general anesthesia |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/02/28 18:10:11 |
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Basic information
Public title
Radio-frequency-ablation for lung cancer under general anesthesia
Acronym
Radio-frequency-ablation for lung cancer under general anesthesia
Scientific Title
Radio-frequency-ablation for lung cancer under general anesthesia
Scientific Title:Acronym
Radio-frequency-ablation for lung cancer
Region
| Japan |
Condition
Condition
Primary lung cancer and metastatic lung cancer
Classification by specialty
| Chest surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
While radio-frequency-ablation (RFA) for lung cancer has been conducted under local anesthesia, it has the following disadvanteges:
(1) Tumor position is usually changed under due to respiration, RFA-prove sometimes falls off the tumor.
(2) During the treatment, temperature of the probe increases, which inflicts pains for patients like burn.
(3) During the treatment, bronchial bleeding sometimes causes airway obstruction.
To eliminate these shortcomings, general anesthesia using tracheal intubation is conducted for RFA for lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
safety and efficacy
Key secondary outcomes
5 years recurrence-free survival
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
For patients with primary or metastatic lung cancer less than 3 cm, the followings are explained: 1. Standard treatment is surgery if resectable, 2. As non-surgical treatment, radiation therapy is the first choice, 3. As another non-surgical treatment, the radio-frequency ablation is also available. When the patient requests the radio-frequency ablation, it will be done.
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
1. Stage I primary lung cancer less than 3 cm.
2. Metastatic lung cancer less than 3 cm.
3. Patient requests RFA.
Key exclusion criteria
Sever pulmonary dysfunction
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
0471451111
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
Funding Source
Organization
None
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
0471451111
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
| 2023 | Year | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2033 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 28 | Day |
Last modified on
| 2023 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057459
