UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005957 |
|---|---|
| Receipt number | R000007041 |
| Scientific Title | Evaluation of safety of percutaneous radiofrequency ablation therapy for metastatic or primary lung cancer |
| Date of disclosure of the study information | 2011/07/15 |
| Last modified on | 2011/07/11 00:41:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of safety of percutaneous radiofrequency ablation therapy for metastatic or primary lung cancer
Acronym
Evaluation of safety of percutaneous radiofrequency ablation therapy for metastatic or primary lung cancer
Scientific Title
Evaluation of safety of percutaneous radiofrequency ablation therapy for metastatic or primary lung cancer
Scientific Title:Acronym
Evaluation of safety of percutaneous radiofrequency ablation therapy for metastatic or primary lung cancer
Region
| Japan |
Condition
Condition
primary or metastatic lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the safety and efficacy of percutaneous radiofrequency ablation therapy for primary or metastatic lung cancer, which is surgically unresectable and deemed to be treatable by locoregional therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety
Key secondary outcomes
Time to Progression
Overall Survival
Objective Response Rate
Tumor-marker assessment
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
| Device,equipment |
Interventions/Control_1
Primary or metastatic lung cancer treated by radiofrequency ablation therapy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Primary or metastatic lung cancer
Cases without distant metastasis except for lung
Cases whose standard treatment is ineffective or unamenable
Key exclusion criteria
Lesion adjacent to large vessels
Cases with active infection
Cases with active asthma
Cases undergone unilateral pneumonectomy
Cases whose performance status is over grade 3
Blood cell count: WBC<2,000/ul, granulocyte<1,000/ul
Platelet<5x104/ul or PT-INR>1.5
Forced expiratory volume<1L
Cases deemed to be inadequate for this treatment
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuichi Tanoue |
Organization
Oita University Faculty of Medicine
Division name
Department of Radiology
Zip code
Address
1-1 Idaigaoka Hasama-machi Yufu 879-5593 JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuichi Tanoue |
Organization
Oita University Faculty of Medicine
Division name
Department of Radiology
Zip code
Address
TEL
Homepage URL
stanoue@oita-u.ac.jp
Sponsor or person
Institute
Oita University Faculty of Medicine, Department of Radiology
Institute
Department
Personal name
Funding Source
Organization
Oita University Faculty of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2011 | Year | 07 | Month | 15 | 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
| 2011 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 11 | Day |
Last modified on
| 2011 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007041
