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Prospective Randomized Phase II Trial: Single Instillation Versus Long-term Prophylactic Intravesical Instillation of Pirarubicin in the Prevention of Bladder Recurrence After Nephroureterectomy for Primary Upper Tract Urothelial Carcinoma (NCT03030157)

Shanghai Pudong Hospital
Shanghai Pudong New Area Gongli Hospital
Up to 30-40% of the patients may develop bladder recurrance after radical nephroureterectomy for primary upper tract urothelial carcinoma. Bladder tumor needs transurethral resection, which is associated with costs of treatment and potential poor prognosis. Although several randomized controlled trial have shown that prophylactic intravesical chemotherapy could prevent bladder tumor recurrence, the optimal schedule and duration of treatment are unkown. The investigators want to determine the efficiacy of single instillation versus long-term intravesical instillation of pirarubicin for bladder recurrence after radical nephrouretectomy for primary upper tract urothelial carcinoma.
  • Drug: pirarubicin(THP)
    Ages eligible for Study
    18 Years and older
    Genders eligible for Study
    All
    Accepts Healthy Volunteers
    No
    Inclusion Criteria:
    • clinically diagnosed with upper tract urothelial carcinoma
    • have no distant metastasis
    • have an ECOG 0 to 2
    • expected to receive radical nephroureterectomy
    Exclusion Criteria:
    • a prior history of bladder or synchronous bladder cancer
    • administration of neoadjuvant chemotherapy
    • the presence of severe complications
    • deny to receive cytoscopy
    • patients with advanced stage (T4)
    • patients with contralateral UTUCs

    1 locations

    China (1)
    • Renji Hospital
      recruiting
      Shanghai, Shanghai, China, 200127
    Status:
    recruiting
    Type:
    Interventional
    Phase:
    Start:
    31 December, 2016
    Updated:
    19 January, 2017
    Participants:
    220
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