UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009682 |
|---|---|
| Receipt number | R000011356 |
| Scientific Title | Randomized control trial of a single postoperative intravesical instillation of THP for prevention of intravesical recurrence after nephroureterectomy |
| Date of disclosure of the study information | 2013/01/04 |
| Last modified on | 2025/03/18 12:44:24 |
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Basic information
Public title
Randomized control trial of a single postoperative intravesical instillation of THP for prevention of intravesical recurrence after nephroureterectomy
Acronym
Randomized control trial of a single postoperative intravesical instillation of THP for prevention of intravesical recurrence after nephroureterectomy
Scientific Title
Randomized control trial of a single postoperative intravesical instillation of THP for prevention of intravesical recurrence after nephroureterectomy
Scientific Title:Acronym
Randomized control trial of a single postoperative intravesical instillation of THP for prevention of intravesical recurrence after nephroureterectomy
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 evaluate the efficacy of a single postoperative intravesical instillation of THP for prevention of intravesical recurrence after nephroureterectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intravesical recurrence rate
Key secondary outcomes
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
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
intravesical instillaiton of THP
Interventions/Control_2
control
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Obtained informed consent
2)Pathologically confirmed urothelial carcinoma
3)No previous treatment of upper urinary tract tumors
4)No metastasis and resectable tumors
5)No previous bladder tumors and concomitant bladder tumors
6)ECOG PS 0-3
7)Have sufficient major organ functions
Key exclusion criteria
1)Need adjuvant chemotherapy according to pathological result
2)Have active cancer except for upper urinary tract tumors
3)Inappropriate patients for this study judged by the physicians
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Yamamoto |
Organization
Hyogo Medical University Hospital
Division name
Department of Urology and Kidney Transplant Center
Zip code
663
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL
0798-45-6366
shingoy@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Suzuki |
Organization
Hyogo Medical University Hospital
Division name
Department of Urology and Kidney Transplant Center
Zip code
6638501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL
0798-45-6366
Homepage URL
tosuzuki@hyo-med.ac.jp
Sponsor or person
Institute
Department of Urology and Kidney Transplant Center, Hyogo Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Urology and Kidney Transplant Center, Hyogo Medical University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kobe city Medical Center General Hospital
Kobe City Nishi-kobe Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo Medical University Hospital
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, japan
Tel
0798456265
h-cresc@hyo-med.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
兵庫医科大学病院(兵庫県)、神戸市立医療センター中央市民病院(兵庫県)、神戸市立西神戸医療センター(兵庫県)、
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 04 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000011356
Publication of results
Published
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Number of participants that the trial has enrolled
100
Results
Thirty-one out of 42 patients in the pirarubicin group remained free of intravesical recurrence (IVR) within 2 years, which was significantly higher than 19 out of 38 control patients (HR:0.47,95%CI:0.23-0.99,p=0.044). We did not have sufficient evidence to detect a difference in terms of OS (HR:0.83,95%CI:0.33-2.10,p=0.69) between the pirarubicin and the control groups. Multivariable analyses of factors associated with IVR revealed that only pirarubicin instillation was associated with IVR.
Results date posted
| 2025 | Year | 03 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Median age was 75 (IQR 69-82) and 79 (IQR 69-84) in the pirarubicin and the control groups, respectively. Pelvic tumor was 26 (62%) and ureteral tumor was 16 (38%) in the pirarubicin group. In the control group, pelvic tumor was 23 (61%) and ureteral tumor was 15 (39%). Cases with ureteroscopic biopsy were 25 (60%) and 17 (45%) in the pirarubicin and the control groups, respectively. EAU high risk was 36 (86%) and high risk was 30 (79%), cases with high grade were 32 (84%) and 26 (72%), cases with muscle invasion were 15 (36%) and 19 (50%) and cases with concomitant carcinoma in situ were 4 (10%) and 4 (11%) in the pirarubicin and the control groups, respectively.
Participant flow
Between August 2012 and January 2019, 97 consecutive radical nephroureterectomy procedures performed were randomly assigned to either the pirarubicin group (n=49) or the control group (n=48). 7 patients in pirarubicin group (6 required adjuvant chemotherapy, 1 non-urothelial cancer) and 7 patients (4 required adjuvant chemotherapy, 3 non-urothelial cancer)in the control group were excluded for the efficacy analysis and remaining 80 patients (42 pirarubicin group and 38 control group) were analyzed.
Adverse events
Intraoperative spillage of the chemotherapy drug into the surgical field was not observed in the pirarubicin group patients. Only one case of Grade 1 postoperative urinary frequency related to instillation was observed among the pirarubicin group patients.
Outcome measures
Intravesical recurrence rate within two years
Overall survival
Adverse events
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2012 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2012 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 03 | Day |
Last modified on
| 2025 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011356
