Retrospective Chart Review of Valstar
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.
Carcinoma in Situ of Bladder
|Study Design:||Observational Model: Case-Only
Time Perspective: Retrospective
|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|
- Event-free survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]Event-free survival defined as recurrence, progression or death from any cause
- Worsening-free Survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]Worsening-free survival defined as recurrence, progression, cystectomy, change of anti-bladder cancer therapy or death from any cause
|Study Start Date:||March 2011|
|Study Completion Date:||October 2011|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01304173
|United States, Tennessee|
|Nashville, Tennessee, United States|
|Principal Investigator:||Michael Cookson, MD||Vanderbilt University|