UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014089 |
|---|---|
| Receipt number | R000016404 |
| Scientific Title | Neo-Adjuvant Chemotherapy plus nephroureterectomy in Kyoto University |
| Date of disclosure of the study information | 2014/05/27 |
| Last modified on | 2018/05/30 09:36:59 |
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Basic information
Public title
Neo-Adjuvant Chemotherapy plus nephroureterectomy in Kyoto University
Acronym
NACNUK trial
Scientific Title
Neo-Adjuvant Chemotherapy plus nephroureterectomy in Kyoto University
Scientific Title:Acronym
NACNUK trial
Region
| Japan |
Condition
Condition
urothelial carcinoma of upper urinary tract
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and safety of neoadjuvant chemotherapy with gemcitabine/CDDP or gemcitabine/CBDCA before radical nephroureterectomy against locally advanced urothelial carcinoma of upper urinary tract
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
3-year disease-free survival rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
neoadjuvant chemotherapy plus radical nephroureterectomy
Interventions/Control_2
radical nephroureterectomy
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 clinical diagonosis of invasive urothelial carcinoma of upper urinary tract (cT2-4 or cTxN+) by imaging and urinary cytology
2 cases without unresectable distant metastasis
3 cases that an radical operation under the general anesthesia is possible.
4 cases with primary urothelial carcinoma (cases with hirtory of non-muscle invasive bladder cancer can be registered.)
5 Performance status 0-1
6 Cases maintaining the functions of the main organs.
Key exclusion criteria
1 Pregnant or potentially women, nursing women
2 Patients with past history of radicalcystectomy
3 Patients with psychiatric diseases
4 Patients with severe or complicated medical conditions, not allowing participation into this protocol
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Ogawa |
Organization
Graduate School of Medicine, Kyoto University
Division name
the Department of Urology
Zip code
Address
Kawahara-cho 54, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3325
ogawao@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Matsui |
Organization
Graduate School of Medicine, Kyoto University
Division name
the Department of Urology
Zip code
Address
Kawahara-cho 54, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3337
Homepage URL
ym1108@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
the Department of Urology, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
the Department of Urology, Graduate School of Medicine, Kyoto University
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
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
| 2014 | Year | 05 | Month | 27 | 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
| 2014 | Year | 05 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2014 | 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
| 2014 | Year | 05 | Month | 27 | Day |
Last modified on
| 2018 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016404
| 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 |
