UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000266 |
|---|---|
| Receipt number | R000000333 |
| Scientific Title | Randomized Controlled Trail on Postoperative Early Intravesical Chemotherapy with Pirarubicin (THP) for Single Superficial Bladder Cancer Comparing Single and Two Times Instillation |
| Date of disclosure of the study information | 2005/10/16 |
| Last modified on | 2018/04/26 16:04:37 |
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Basic information
Public title
Randomized Controlled Trail on Postoperative Early Intravesical Chemotherapy with Pirarubicin (THP) for Single Superficial Bladder Cancer Comparing Single and Two Times Instillation
Acronym
Postoperative Early Intravesical Chemotherapy with Pirarubicin (THP) for Single Superficial Bladder Cancer
Scientific Title
Randomized Controlled Trail on Postoperative Early Intravesical Chemotherapy with Pirarubicin (THP) for Single Superficial Bladder Cancer Comparing Single and Two Times Instillation
Scientific Title:Acronym
Postoperative Early Intravesical Chemotherapy with Pirarubicin (THP) for Single Superficial Bladder Cancer
Region
| Japan |
Condition
Condition
Superficial Bladder Cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare single intravesical instillation and two times intravesical instillation with pirarubicin
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Recurrence free survival
Key secondary outcomes
Recurrence free rate
Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Single postoperative instillation of Pirarubicin (30 mg/50 mL) immediately after TUR-Bt
Interventions/Control_2
Two times postoperative instillations of Pirarubicin immediately after and one day after TUR-Bt
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 with stage Ta or T1 superficial bladder cancer
Patients with single tumor (primary/single, recurrent/single)(In recurrent cases, although patients who have been treated with intravesical instillation of anticancer agents (including all anticancer agents except for BCG) are eligible, the intravesical chemotherapy must have been conducted more than 4 weeks before)
Pathologically confirmed urothelial carcinoma (Because no histopathological diagnosis had been made at the time of registration, eligibility can be judged at the time of the histopathological diagnosis)
Patients with complete tumor resection by TUR-Bt(It shall be judged during operation whether the tumor has been completely resected)
Patients who can undergo cytoscopy periodically, and in whom the presence or absence of recurrence can be monitored
Patients age 20 and over
Patients from whom written informed consent has been obtained
Key exclusion criteria
Patients with prior history of BCG therapy
Patients with CIS, or treatment history of CIS
Patients with treatment history of invasive bladder carcinoma
Patients with extravesical lesions (in the upper urinary tract and urethra), or past history of related treatment
Patients with severe impairments in the bone marrow, liver, kidney or cardiac function
Patients with active double cancer
Patients who are judged not to be eligible by the physician in charge
Target sample size
200
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 Sciences
Division name
Department of Urology
Zip code
Address
2-5-1,Shikata-cho,Okayama,700-8558,Japan
TEL
086-235-7151
uro2@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyasu Tsushima |
Organization
NHO Okayama Medical Center
Division name
Department of Urology
Zip code
Address
1711-1,Tamasu,Okayama,701-1192,Japan
TEL
086-294-9911
Homepage URL
http://uro.jp/thp
tsushima@okayamamc.jp
Sponsor or person
Institute
Department of Urolofgy, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
None
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
岡山大学病院（岡山県）
岡山医療センター（岡山県）
高知医療センター（高知県）
広島市民病院（広島県）
香川県立中央病院（香川県）
Other administrative information
Date of disclosure of the study information
| 2005 | Year | 10 | Month | 16 | Day |
Related information
URL releasing protocol
http://uro.jp/thp
Publication of results
Published
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
| 2004 | Year | 10 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 10 | Month | 16 | Day |
Last modified on
| 2018 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000333
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