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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000266
Receipt No. 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

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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
Email 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
Email tsushima@okayamamc.jp

Sponsor
Institute Department of Urolofgy, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000333

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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