Background: Following radical nephro-ureterectomy for urothelial carcinoma of the upper urinary tract (UUT), the reported bladder recurrence rate of urothelial carcinoma is 22–47%. A single intravesical instillation of chemotherapy within 10 days following nephro-ureterectomy has the potential to decrease the risk of a bladder recurrence significantly. Despite recommendation by the European Association of Urology guideline to administer a single instillation postoperatively, the compliance rate is low because the risk of extravasation of chemotherapy.
Aim: To reduce the risk of bladder cancer recurrence by a single intravesical instillation of Mitomycin immediately (within 3 h) before radical nephro-ureterectomy or partial ureterectomy.
Methods: Adult patients (age ≥ 18 years) with a (suspicion of a) urothelial carcinoma of the UUT undergoing radical nephro-ureterectomy or partial ureterectomy will be eligible and will receive a single intravesical instillation of Mitomycin within 3 h before surgery. In total, 170 patients will be included in this prospective, observational study. Follow-up will be according to current guidelines.
Results: The primary endpoint is the bladder cancer recurrence rate up to two years after surgery. Secondary endpoints are: a) the compliance rate; b) oncological outcome; c) possible side-effects; d) the quality of life; e) the calculation of costs of a single neoadjuvant instillation with Mitomycin and f) molecular characterization of UUT tumors and intravesical recurrences.
Conclusions: A single intravesical instillation of Mitomycin before radical nephro-ureterectomy or partial ureterectomy may reduce the risk of a bladder recurrence in patients treated for UUT urothelial carcinoma and will circumvent the disadvantages of current therapy.

Additional Metadata
Keywords Bladder cancer, Chemotherapy, Nephro-ureterectomy, Upper urinary tract, Urothelial carcinoma
Persistent URL dx.doi.org/10.1016/j.conctc.2018.01.007, hdl.handle.net/1765/104511
Journal Contemporary Clinical Trials Communications
Citation
van Doeveren, T. (T.), van Leeuwen, P, Aben, K.K.H, Aa, M.A, Barendrecht, M. (M.), Boeve, E.R, … Boormans, J.L. (2018). Reduce bladder cancer recurrence in patients treated for upper urinary tract urothelial carcinoma. Contemporary Clinical Trials Communications, 9, 121–129. doi:10.1016/j.conctc.2018.01.007