Chemoablation for Low-Grade Bladder Cancer

Summary

The goal of this single arm, prospective, open-label, investigator-initiated Phase 2 clinical trial is to evaluate the efficacy of intravesical chemoablation in patients with low grade bladder cancer.

Timeline

Start

2023-12-27

Primary completion

2027-11

Completion

2027-11

Publications

• Background Brausi MA, Gontero P, Altieri V, Colombo R, Conti I, Bono AV. Can gemcitabine instillation ablate solitary low-risk non-muscle-invasive bladder cancer? Results of a phase II marker lesion study. Urol Int. 2011;87(4):470-4. doi: 10.1159/000331727. Epub 2011 Nov 11.
• Background Gardmark T, Carringer M, Beckman E, Malmstrom PU; Members of the Intravesical Gemcitabine Study Group. Randomized phase II marker lesion study evaluating effect of scheduling on response to intravesical gemcitabine in recurrent Stage Ta urothelial cell carcinoma of the bladder. Urology. 2005 Sep;66(3):527-30. doi: 10.1016/j.urology.2005.03.084.
• Background Maffezzini M, Campodonico F, Canepa G, Capponi G, Fontana V. Short-schedule intravesical gemcitabine with ablative intent in recurrent Ta-T1, G1-G2, low- or intermediate-risk, transitional cell carcinoma of the bladder. Eur Urol. 2007 Apr;51(4):956-61. doi: 10.1016/j.eururo.2006.08.038. Epub 2006 Sep 20.
• Background Campodonico F, Canepa G, Capponi G, Bozzo L, Maffezzini M. Intravesical gemcitabine in recurrent superficial bladder carcinoma: preliminary results on ablative efficacy and tolerability. Anticancer Res. 2005 May-Jun;25(3c):2381-4.
• Background Serretta V, Galuffo A, Pavone C, Allegro R, Pavone-MacAluso M. Gemcitabine in intravesical treatment of Ta-T1 transitional cell carcinoma of bladder: Phase I-II study on marker lesions. Urology. 2005 Jan;65(1):65-9. doi: 10.1016/j.urology.2004.08.027.
• Background Gontero P, Casetta G, Maso G, Sogni F, Pretti G, Zitella A, Frea B, Tizzani A. Phase II study to investigate the ablative efficacy of intravesical administration of gemcitabine in intermediate-risk superficial bladder cancer (SBC). Eur Urol. 2004 Sep;46(3):339-43. doi: 10.1016/j.eururo.2004.05.001.

Drugs

Indications