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)
Who is this study for? Patients with urinary bladder cancer
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Greece
Urology Department, University of Thessaly, University Hospital of Larissa
RECRUITING
Larissa
Contact Information
Primary
Vasileios Tzortzis, Professor
urologydpt.uth@gmail.com
00302413502811
Backup
Lampros Mitrakas, Consultant
lamprosmit@gmail.com
00302413501325
Time Frame
Start Date:2021-12-14
Estimated Completion Date:2026-10
Participants
Target number of participants:180
Treatments
Active_comparator: Gemcitabine
Bladder cancer patients, who are treated with a transurethral resection of a bladder tumor, receive postoperatively, within 6 hours after the resection, an immediate single intravesical instillation with gemcitabine hydrochloride 2gr in 100ml of saline for 45-60 minutes and continuous saline irrigation for 24 hours
Active_comparator: Epirubicin
Bladder cancer patients, who are treated with a transurethral resection of a bladder tumor, receive postoperatively, within 6 hours after the resection, an immediate single intravesical instillation with epirubicine hydrochloride 50mg in 50ml of saline for 45-60 minutes and continuous saline irrigation for 24 hours