Spots Global Cancer Trial Database for Retrospective Chart Review of Valstar

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Trial Identification

Brief Title: Retrospective Chart Review of Valstar

Official Title: A Retrospective Analysis to Evaluate the Effectiveness, Safety and Tolerability of Intravesical Valrubicin for the Treatment of Bladder Carcinoma in Situ in Clinical Practice

Study ID: NCT01304173

Conditions

Carcinoma in Situ of Bladder

Interventions

Study Description

Brief Summary: This is an observational study involving a retrospective review of medical records of adult patients who have been treated with intravesical valrubicin for bladder carcinoma in situ (CIS) since October 2009.

Detailed Description: Initial treatment for bladder CIS is TURBT followed by intravesical immunotherapy with BCG. Valrubicin is approved by the FDA for the treatment of BCG-refractory bladder CIS in patients for whom immediate cystectomy would be associated with unacceptable morbidity or mortality. The recommended course of therapy is 6 doses of 800 mg each administered intravesically once a week. While the benefit risk profile of valrubicin has been established in several clinical trials, current data on effectiveness and tolerability when used in clinical practice are lacking. This protocol outlines a retrospective study to evaluate the effectiveness, safety and tolerability of intravesical valrubicin in the treatment of NMIBC in a clinical practice setting.