Transurethral Resection of Bladder Tumor (TURBT) Combined With Adjuvant Intravenous GC Chemotherapy for Non-muscle-invasive Bladder Cancer
Summary
It is still a challenge for urologic surgeon to prevent the post transurethral resection of bladder tumor (TURBT) recurrence of moderate-high risk non-muscle invasive bladder tumor. Adjuvant chemotherapy is a standard treatment for local progressive bladder tumor, which contains mainstream GC treatment scheme. It is common to observe clinically moderate-high risk NMIBC recurrence after routine intravesical instillation.Systematic chemotherapy can eliminate remained tumor cells especially those from mucosa basal cells so as to improve the prognosis of patients. Our clinical trial aims to investigate whether the utilization of combination of GC treatment scheme and epirubicin instillation would decrease the recurrence of moderate-high risk NMIBC.
Timeline
- Start
- 2016-01
- Primary completion
- 2020-12
- Completion
- 2020-12
Publications
- Results Babjuk M, Oosterlinck W, Sylvester R, Kaasinen E, Bohle A, Palou-Redorta J, Roupret M; European Association of Urology (EAU). EAU guidelines on non-muscle-invasive urothelial carcinoma of the bladder, the 2011 update. Eur Urol. 2011 Jun;59(6):997-1008. doi: 10.1016/j.eururo.2011.03.017. Epub 2011 Mar 22.
- Results Sylvester RJ, Oosterlinck W, Holmang S, Sydes MR, Birtle A, Gudjonsson S, De Nunzio C, Okamura K, Kaasinen E, Solsona E, Ali-El-Dein B, Tatar CA, Inman BA, N'Dow J, Oddens JR, Babjuk M. Systematic Review and Individual Patient Data Meta-analysis of Randomized Trials Comparing a Single Immediate Instillation of Chemotherapy After Transurethral Resection with Transurethral Resection Alone in Patients with Stage pTa-pT1 Urothelial Carcinoma of the Bladder: Which Patients Benefit from the Instillation? Eur Urol. 2016 Feb;69(2):231-44. doi: 10.1016/j.eururo.2015.05.050. Epub 2015 Jun 16.
- Results Villavicencio H, Rodriguez Faba O, Palou J, Gausa L, Algaba F, Marcuello E. Bladder preservation strategy based on combined therapy in patients with muscle-invasive bladder cancer: management and results at long-term follow-up. Urol Int. 2010;85(3):281-6. doi: 10.1159/000316076. Epub 2010 Jul 30.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 70 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | — |
| Subject | Gemcitabine | Small molecule | 1200 mg/m2 | — |