The study of Immucyst for the prophylaxis of the superficial bladder cancer at a intermediate risk for the intravesical recurrence

UMIN ID: UMIN000001321

Registered date:20/08/2008

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: superficial bladder cancer at the intermediate risk
• Date of first enrollment: 2007/02/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): intravesical instillation of Immucsyt

Outcome(s)

• Primary Outcome: Intravasecal recurrence

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) The history or the presence of Invasive bladder cancer with T2 or more 2) untreated CIS 3) single tumor of Ta, G1 4) tumor of T1,G3 5) associated malignant tumors at the upper urinary tract and/or the urethra 6) the presence of metastases to the lymph nodes and/or the distant organ or active double cancer 7) The presence of active tuberculosis infection with or without the anti-tuberculosis therapy 8) Contraindication for BCG instillation therapy

Related Information

• Primary Sponsor: Department of Urology, Tokyo Women's Medical University
• Secondary Sponsor: none
• Source(s) of Monetary Support: Nippon Kayaku,none
• Secondary ID(s): 1009