UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025209 |
|---|---|
| Receipt number | R000028999 |
| Scientific Title | Efficacy of presurgical targeting therapy on tumor shrinkage in patients with advanced renal cell carcinoma |
| Date of disclosure of the study information | 2016/12/10 |
| Last modified on | 2022/12/05 21:57:43 |
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Basic information
Public title
Efficacy of presurgical targeting therapy on tumor shrinkage in patients with advanced renal cell carcinoma
Acronym
Efficacy of presurgical targeting therapy in patients with advanced renal cell carcinoma
Scientific Title
Efficacy of presurgical targeting therapy on tumor shrinkage in patients with advanced renal cell carcinoma
Scientific Title:Acronym
Efficacy of presurgical targeting therapy in patients with advanced renal cell carcinoma
Region
| Japan |
Condition
Condition
Renal cell carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluating efficacy of presurgical targeting therapy on tumor shrinkage in patients with advanced renal cell carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
adiologic tumor response comparison among Response Evaluation Criteria in Solid Tumors (RECIST), Choi, and contrast medium enhancement reduction (CMER)
Key secondary outcomes
Pathological downstaging, theatment related adverse events (AE), postoperative complications, Ki67/MIB1 status, and tumor necrosis, pathological and molecular analysis to predict poor prognosis, progression free, cancer specific and overall survival
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
targeting therapy (TKI or mTORi) for aboout 3 months, and then, undergo radical nephrectomy
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Males, 20 years or older, in patients with advanced renal cell carcinoma without prior targeting therapy.
Clinically T3-4, or oligometastatic disease (not multiple, small, or resectable) who underwent tumor biopsy prier to targeting therapy
Agree to use TKI or mTORi prior to radical nephrectomy.
Key exclusion criteria
Sarcomatous renal cell carcinoma, not indicated for tyrosine kinase inhibitors(TKI) or mammalian target of rapamycin inhibitors(mTORi), untreated brain metastasis, active gastrointestinal hemorrhage, poor general health (ECOG PS > 2), major concomitant disease, other medical condition likely to result in death within 6 months after the treatment initiation.
Clinical evidence of any of unstable diseases including cardiovascular, infectious, immune, nervous system disease, and other active malignancies that influenced on therapy for renal cell carcinoma.
History of drug, alcohol, or substance abuse.
Have any condition, limitation, or disease that could, in the judgment of the investigator, preclude evaluation of response to targeting therapy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Hatakeyama |
Organization
Hirosaki University Hospital
Division name
Urology
Zip code
036-8562
Address
53 Honchou, Hirosaki
TEL
0172395091
shingoh@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Hatakeyama |
Organization
Hirosaki University Hospital
Division name
Urology
Zip code
036-8562
Address
53 Honchou, Hirosaki
TEL
0172395091
Homepage URL
shingoh@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hirosaki University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hirosaki Universicy IRB
Address
5 Zaifu-chou, Hirosaki
Tel
0172395091
rinri@hirosaki-u.ac.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
弘前大学 医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
34
Results
The median radiologic tumor response by RECIST, Choi, and CMER was -19%, -24%, and -49%, respectively. Among the radiologic tumor response tests, CMER showed a higher association with tumor necrosis in surgical specimens than others. Ki67/MIB1 status was significantly decreased in surgical specimens than in biopsy specimens. The magnitude of the slope of the regression line associated with the tumor necrosis percentage was greater in CMER than in Choi and RECIST.
Results date posted
| 2022 | Year | 12 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A quantitative tumor response evaluation to molecular-targeting agents in advanced renal cell carcinoma (RCC) is debatable. We aimed to evaluate the relationship between radiologic tumor response and pathological response in patients with advanced RCC who underwent presurgical therapy.
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2012 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2012 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 09 | Day |
Last modified on
| 2022 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028999
