UMIN-CTR Clinical Trial

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
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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
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IRB Contact (For public release)
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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
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Baseline Characteristics
Participant flow
Adverse events
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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
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Research case data
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