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RECRUITINGPhase 3INTERVENTIONAL

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

A Prospective Phase III Randomized Clinical Trial Comparing the Effectiveness of Immediate Postoperative Intravesical Instillation With Either Gemcitabine Hydrochloride or Epirubicin Hydrochloride in Patients With Urinary Bladder Cancer (Gemcitabine Epirubicin Normal SAline)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Primary urinary bladder tumor - Secondary urinary bladder tumor (recurrence) - Bipolar or monopolar resection - Creat \<2.2mg/dl - 35% \<Hct \<52% - White bloode cells count WBC ≥3000 / μL - 75000 \<PLT \<500000 / μL - 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 Who Should NOT Join This Trial: - More than 2 low grade / high differentiation (low grade / LG) diagnosed by tissue sample (biopsy-confirmed) bladder tumors in the last 18 months before the transurethral resection of the bladder tumor - High grade / low differentiation (HG) diagnosed by tissue sample (biopsy-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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Primary urinary bladder tumor * Secondary urinary bladder tumor (recurrence) * Bipolar or monopolar resection * Creat \<2.2mg/dl * 35% \<Hct \<52% * White bloode cells count WBC ≥3000 / μL * 75000 \<PLT \<500000 / μL * 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

Treatments Being Tested

DRUG

Gemcitabine Hydrochloride combined with continuous saline irrigation

Immediate single intravesical instillation with gemcitabine combined with continuous saline irrigation in bladder cancer patients who are treated with a transurethral resection of the tumor

DRUG

Epirubicin Hydrochloride combined with continuous saline irrigation

Immediate single intravesical instillation with epirubicin combined with continuous saline irrigation in bladder cancer patients who are treated with a transurethral resection of the tumor

Locations (1)

Urology Department, University of Thessaly, University Hospital of Larissa
Larissa, Larissa/Thessaly, Greece