UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004079 |
|---|---|
| Receipt number | R000004913 |
| Scientific Title | The usefulness of RFA for the pulmonary metastasis associated with kidney cancer |
| Date of disclosure of the study information | 2010/08/20 |
| Last modified on | 2014/08/20 09:43:17 |
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Basic information
Public title
The usefulness of RFA for the pulmonary metastasis associated with kidney cancer
Acronym
RFA-Lung-RCC
Scientific Title
The usefulness of RFA for the pulmonary metastasis associated with kidney cancer
Scientific Title:Acronym
RFA-Lung-RCC
Region
| Japan |
Condition
Condition
the cases with pulmonary metastasis associated with kidney cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of RFA for the pulmonary metastasis associated with kidney cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Over all survival
Key secondary outcomes
Local recurrence
Cause specific survival
Progression free survival
QOL
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
the treatment with RFA
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) diagnosis of kidney cancer
2) pulmonary metastasis diagnosed with radiological examination
3) pulmonary sites and size (less than 3 and less than 3cm)
4) resistance against immunotherapy
5) WHO 0 or 1
6) Received informed and consensus to entry this study
Key exclusion criteria
1) General dysfunction including bone marrow function, hepatic function, renal function, heart function
2) Active other organ originated cancer
3) The physician deny to entry
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki sugimura |
Organization
mie university
Division name
urology
Zip code
Address
Edobashi2-174, Tsu, Mie , Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norihito Soga |
Organization
Mie university
Division name
urology
Zip code
Address
Edobashi2-174, Tsu, Mie , Japan
TEL
Homepage URL
Sponsor or person
Institute
M-CURE
Institute
Department
Personal name
Funding Source
Organization
Mie university
Organization
Division
Category of Funding Organization
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
| 2010 | Year | 08 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2007 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 02 | Month | 20 | Day |
Date of closure to data entry
| 2013 | Year | 02 | Month | 20 | Day |
Date trial data considered complete
| 2013 | Year | 02 | Month | 20 | Day |
Date analysis concluded
| 2013 | Year | 02 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 08 | Month | 20 | Day |
Last modified on
| 2014 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004913
