JRCT ID: jRCT2080220126
Registered date:21/09/2005
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | Recurrent or multiple NMIBC |
Date of first enrollment | 21/09/2005 |
Target sample size | |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | investigational material(s) Generic name etc : PMCJ-9(BCG Connaught strain) INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : intravesical instillation |
Outcome(s)
Primary Outcome | Recurrence-free survival time, safety |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | <= 79age old |
Gender | Both |
Include criteria | 1. Granting of written informed consent by the patient 2. Resection of all tumors by TURBT, tumors are histopathologically confirmed NMIBC ( transitional carcinoma). 3. Sufficient function of the major organs 4. Performance status 0-2 etc. |
Exclude criteria | 1. Muscle-invasive bladder cancer 2. Carcinoma in situ (CIS) or history thereof 3. History of systemic chemotherapy, intra-arterial chemotherapy or radiation therapy for bladder cancer 4. Patient having an immunosuppressive thrapy, etc. |
Related Information
Primary Sponsor | Nippon Kayaku Co., Ltd. |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | JapicCTI-050128 |
Contact
Public contact | |
Name | |
Address | FAX o3-3598-5883 |
Telephone | |
Affiliation | Nippon Kayaku CO.LTD |
Scientific contact | |
Name | |
Address | |
Telephone | |
Affiliation |