Radio-Immunotherapy Before Cystectomy in Locally Advanced Urothelial Carcinoma of the Bladder

  • STATUS
    Recruiting
  • End date
    Aug 24, 2022
  • participants needed
    33
  • sponsor
    Technische Universität München
Updated on 24 January 2021
radical cystectomy
carcinoma
gilbert's syndrome
metastasis
neutrophil count
lymphadenectomy
nivolumab
transitional cell carcinoma
bladder tumor
bladder carcinoma
hydronephrosis
advanced urothelial carcinoma

Summary

A prospective, single arm, multicenter, Phase II-Trial to assess safety and efficacy of preoperative Radiation therapy before radical CystEctomy combined with ImmunoTherapy in locally advanced urothelial carcinoma of the bladder

Description

Patients with locally advanced bladder cancer have a poor prognosis despite radical surgical therapy. The addition of perioperative combination chemotherapy did not add significant benefit to surgery alone. There is data indicating a synergistic effect of radiation and immunotherapy. Therefore, combined application of radiotherapy with Nivolumab before radical cystectomy might lead to improved cure rates and local control in this poor prognosis group with locally advanced bladder cancer. The aim of this phase-II study is to assess feasibility and safety of immunotherapy combined with neoadjuvant radiation before radical cystectomy.

Details
Condition urinary tract neoplasm, bladder cancer, bladder disorder, Urothelial Cancer, Bladder Disorders, Bladder Carcinoma, Urologic Cancer, carcinoma of the bladder
Treatment Nivolumab, Radiation therapy of the pelvis, Radical cystectomy with standardized pelvic lymphadenectomy
Clinical Study IdentifierNCT03529890
SponsorTechnische Universität München
Last Modified on24 January 2021

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