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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Superficial Bladder Cancer | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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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 |
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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 | |
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Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Date trial data considered complete |
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Other | |
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Management information | |||||||
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Last modified on |
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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 |