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. 2018 Feb 28:9:121-129.
doi: 10.1016/j.conctc.2018.01.007. eCollection 2018 Mar.

Reduce bladder cancer recurrence in patients treated for upper urinary tract urothelial carcinoma: The REBACARE-trial

T van Doeveren  1 , P J van Leeuwen  1 , K K H Aben  2   3 , M van der Aa  4 , M Barendrecht  5 , E R Boevé  6 , E B Cornel  7 , A G van der Heijden  3 , K Hendricksen  8 , W Hirdes  9 , A Kooistra  10 , B Kroon  11 , A M Leliveld  12 , R P Meijer  13 , H van Melick  14 , B Merks  15 , T M de Reijke  16 , P de Vries  17 , L F A Wymenga  18 , B Wijsman  19 , J L Boormans  1
Affiliations

Reduce bladder cancer recurrence in patients treated for upper urinary tract urothelial carcinoma: The REBACARE-trial

T van Doeveren et al. Contemp Clin Trials Commun. .

Erratum in

Abstract

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.

Keywords: Bladder cancer; Chemotherapy; Nephro-ureterectomy; Upper urinary tract; Urothelial carcinoma.

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