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OncoMatch/Clinical Trials/NCT04947059

Effectiveness of an Immediate Postoperative Intravesical Instillation With Either Gemcitabine or Epirubicin in Patients With Urinary Bladder Cancer (Gemcitabine Epirubicin Normal SAline)

Is NCT04947059 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Gemcitabine Hydrochloride combined with continuous saline irrigation and Epirubicin Hydrochloride combined with continuous saline irrigation for bladder cancer.

Phase 3RecruitingUniversity of ThessalyNCT04947059Data as of May 2026

Treatment: Gemcitabine Hydrochloride combined with continuous saline irrigation · Epirubicin Hydrochloride combined with continuous saline irrigationThe natural history of non-muscle-invasive bladder cancer is characterised by recurrence and progression. We compare the effectiveness of gemcitabine hydrochloride and epirubicin hydrochloride, in combination with continuous saline irrigation, as an immediate single intravesical instillation in the potential reduction of the disease recurrence as well as progression.

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Extracted eligibility criteria

Cancer type

Urothelial Carcinoma

Disease stage

Excluded: Stage PT2

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: intravesical instillation of chemotherapeutic agent or BCG

Intravesical instillation of chemotherapeutic agent or BCG in the last 6 months before the transurethral resection of the bladder tumor

Cannot have received: pelvic radiotherapy

History of pelvic radiotherapy

Lab requirements

Blood counts

35% <Hct <52%; WBC ≥3000 / μL; 75000 <PLT <500000 / μL

Kidney function

Creat <2.2mg/dl

Liver function

Alkaline phosphatase, total bilirubin, SGOT, SGPT: values as high as 2 times above the upper normal limit

Creat <2.2mg/dl; 35% <Hct <52%; WBC ≥3000 / μL; 75000 <PLT <500000 / μL; Alkaline phosphatase, total bilirubin, SGOT, SGPT: values as high as 2 times above the upper normal limit

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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