UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003748 |
|---|---|
| Receipt number | R000004540 |
| Scientific Title | The evaluation of RFA in unresectable advanced kidney cancer associated with the molecular target therapy as neo-adjuvant setting |
| Date of disclosure of the study information | 2010/06/15 |
| Last modified on | 2014/06/16 12:44:26 |
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Basic information
Public title
The evaluation of RFA in unresectable advanced kidney cancer associated with the molecular target therapy as neo-adjuvant setting
Acronym
Neo-RFA
Scientific Title
The evaluation of RFA in unresectable advanced kidney cancer associated with the molecular target therapy as neo-adjuvant setting
Scientific Title:Acronym
Neo-RFA
Region
| Japan |
Condition
Condition
over T1b kidney cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of the RFA in the unrest able kidney cancer associated with molecular target therapy as neo-adjuvant setting.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
local progression free survival
adverse event
Key secondary outcomes
progression free survival
over all survival
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
| Medicine | Maneuver |
Interventions/Control_1
molecular target therapy,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
kidney cancer
T1b any LN any M
20years-80years
male and female
PS o or 1
Key exclusion criteria
1) Heart pace maker
2) Difficult to insert the needle because of anatomical risk (artery, nerve, ureter)
3) Difficult to insert the needle because of anatomical risk (hilum, internal organ)
4) Difficult to calculate the tumor, malti focal tumor
5) Tendency of bleeding
6) Difficult to stop the medication to control coagulation or degradation of plate
7) Allergy to contrast medium
8) Complicated with infection
9) Active infection
10) Fever over 38 centigrade
11) Difficult to prolong the treatment for other focal therapy
12) Difficult to stop the chemotherapy and immunotherapy
13) The treatment history of the focal therapy to that location
14) Pregnancy
15) Justice to reject decided by main physician.
Target sample size
29
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
2-174, Edobashi, Tsu, mie
TEL
059-232-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norihito Soga |
Organization
Mie university
Division name
urology
Zip code
Address
TEL
Homepage URL
n-soga@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie university
Institute
Department
Personal name
Funding Source
Organization
none
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
三重大学泌尿器科(三重県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | 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
Completed
Date of protocol fixation
| 2010 | Year | 06 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 14 | Day |
Last modified on
| 2014 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004540
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
