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

• Status: Not yet recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Thessaly
• Treatments: Epirubicin; Gemcitabine

Criteria

Inclusion Criteria:

• Primary urinary bladder tumor

• Secondary urinary bladder tumor (recurrence)

• Bipolar or monopolar resection

• Creat <2.2mg/dl

• 35%- White bloode cells count WBC ≥3000 / μL

• 75000

• Urine culture: negative / sterile

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

• Good clinical condition (according to Eastern Cooperative Oncology Group PS ≤ 1)

• CT Urography without findings suggesting an upper urinary tract tumor in the last 3 months before the transurethral resection of the bladder tumor

Exclusion Criteria:

• More than 2 low grade / high differentiation (low grade / LG) histologically confirmed bladder tumors in the last 18 months before the transurethral resection of the bladder tumor

• High grade / low differentiation (HG) histologically confirmed bladder tumor in the last 9 months before the transurethral resection of the bladder tumor

• Those who undergo a transurethral resection of a bladder tumor according to the Guidelines of the European Association of Urology for non-muscle-invasive bladder cancer: incomplete resection of tumor, absence of muscle fibers in the sample with the exception of: Ta / LG-G1, primary Cis and finally, pT1 tumors

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

• History of non-urothelial bladder cancer

• Stage of disease pT2 (muscle-invasive bladder cancer)

• Presence of a tumor in the urethra

• Upper urinary tract malignancy (present or anamnestically)

• History of pelvic radiotherapy

• Histrory of another malignancy in the last 5 years before the transurethral resection of the bladder tumor