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BL11 Details
Status: Closed 
Activation Date: 2006APR12
Closing Date: 2008DEC04
Phase: III 

Description: A Phase III Study of Iressa? in Combination with Intravesical BCG versus Intravesical BCG Alone in High Risk Superficial Transitional Cell Carcinoma of the Bladder 

Eligibility: Patients with high risk Ta, Tis or T1 superficial bladder cancer, who completed transurethral resection of all visible bladder lesions within 21 to 60 days prior to randomization, and without other evidence of metastasis. 

Objective: Comparisons of time to treatment failure, complete response rate for patients with carcinoma in situ (Tis) at randomization, time to recurrence, time to progression, overall survival, adverse event and safety, and quality of life. Evaluate prognostic significance of tumour marker expression on the primary tumour and impact of therapy on tumour marker expression. 

Participation: Open to member centres 

Lay Description: The purpose of this study is to compare the effects on you and your superficial bladder cancer of a new drug Iressa? given with another commonly-used treatment to treat this disease. This research is being done because superficial bladder cancer often comes back after surgery. Iressa? has been shown to shrink cancer in animals. It is not clear, however, if it can offer better results when it is given together with intravesical BCG (BCG vaccine that is put into the bladder) compared to BCG put into the bladder alone. The combination of BCG put into the bladder and Iressa? has not been studied before. 

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