UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005767 |
|---|---|
| Receipt number | R000006816 |
| Scientific Title | Prospective study of the efficacy of intravesical chemotherapy with THP against subsequent bladder cancer after nephrouretectomy (NUx) for upper urinary tract carcinoma (UUTC). |
| Date of disclosure of the study information | 2011/07/01 |
| Last modified on | 2011/06/13 14:22:09 |
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Basic information
Public title
Prospective study of the efficacy of intravesical chemotherapy with THP against subsequent bladder cancer after nephrouretectomy (NUx) for upper urinary tract carcinoma (UUTC).
Acronym
Prospective study of the efficacy of intravesical chemotherapy against bladder recurrence after NUx for UUTC.
Scientific Title
Prospective study of the efficacy of intravesical chemotherapy with THP against subsequent bladder cancer after nephrouretectomy (NUx) for upper urinary tract carcinoma (UUTC).
Scientific Title:Acronym
Prospective study of the efficacy of intravesical chemotherapy against bladder recurrence after NUx for UUTC.
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 of intravesical chemotherapy with THP against subsequent bladder cancer after nephrouretectomy (NUx) for upper urinary tract carcinoma (UUTC).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Bladder recurrence free rate.
Key secondary outcomes
Disease-specific survival.
Safety.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intravesical infusion of pirarubicin (30mg/40ml) immediately after nephroureterectomy.
Interventions/Control_2
No intravesical infusion of pirarubicin immediately after 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients 20 or older
Performance status scale 0~1
Patients diagnosed as having upper urinary tract carcinoma by CT, urine cytology or pyeloureteroscopy.
Tumor-stage is diagnosed by imaging test as lower than T3 and N0M0
Patients expected survival is 3 months or longer
Patients must have functioning organs
Liver :AST and ALT should be within 3 times the range of the limit set by their assigned facility
heart :no significant abnormal electrocardiogram readings(irregular heartbeat, angina, heart failure, heart infarction)
Kidney :no kidney failure
Patients must give written informed consent
Key exclusion criteria
Prior bladder cancer
Carcinoma in situ, or treatment history for carcinoma in situ
Severe diabetes
Uncontrollable complications
Severe mental diseases
Active multiple cancers
Anthracycline sensitivity
Patients diagnosed as inappropriate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromi Kumon |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science.
Division name
Department of Urology
Zip code
Address
Shikata-cho 2-5-1, north ward, Okayama, 700-8558, Japan
TEL
086-235-7287
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Kobayashi |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science.
Division name
Department of Urology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science.
Institute
Department
Personal name
Funding Source
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science.
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
| 2011 | Year | 07 | Month | 01 | 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 | 01 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 13 | Day |
Last modified on
| 2011 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006816
