Contemporary Clinical Trials Communications (Mar 2018)

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

  • T. van Doeveren,
  • P.J. van Leeuwen,
  • K.K.H. Aben,
  • M. van der Aa,
  • M. Barendrecht,
  • E.R. Boevé,
  • E.B. Cornel,
  • A.G. van der Heijden,
  • K. Hendricksen,
  • W. Hirdes,
  • A. Kooistra,
  • B.K. Kroon,
  • A.M. Leliveld,
  • R.P. Meijer,
  • H. van Melick,
  • B. Merks,
  • T.M. de Reijke,
  • P. de Vries,
  • L.F.A. Wymenga,
  • B. Wijsman,
  • J.L. Boormans

DOI
https://doi.org/10.1016/j.conctc.2018.01.007
Journal volume & issue
Vol. 9, no. C
pp. 121 – 129

Abstract

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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.

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