Comparing Gemcitabine and Epirubicin for Bladder Cancer Treatment
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)
This study is testing whether gemcitabine or epirubicin works better to prevent bladder cancer from coming back after surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Thessaly Academic / other |
| Locations | 1 site (Larissa, Larissa/Thessaly) |
| Trial ID | NCT04947059 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of two chemotherapeutic agents, gemcitabine and epirubicin, administered as an immediate postoperative intravesical instillation in patients with urinary bladder cancer. The study aims to determine which agent, combined with continuous saline irrigation, better reduces the recurrence and progression of non-muscle-invasive bladder cancer following transurethral resection of tumors. By comparing these two treatments, the trial seeks to provide insights into optimal postoperative care for bladder cancer patients.
Who should consider this trial
Good fit: Ideal candidates include patients with primary or recurrent non-muscle-invasive bladder tumors who are in good clinical condition.
Not a fit: Patients with high-grade bladder tumors or multiple low-grade tumors in the recent past may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols that significantly reduce the recurrence of bladder cancer.
How similar studies have performed: Previous studies have shown that immediate postoperative intravesical instillation significantly reduces recurrence rates, but this specific comparison of gemcitabine and epirubicin is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Larissa, Larissa/Thessaly
- Urology Department, University of Thessaly, University Hospital of Larissa — Larissa, Larissa/Thessaly, Greece (Recruiting)
Study contacts
- Principal investigator: Vasileios Tzortzis, Professor — Urology Department, University of Thessaly, University Hospital of Larissa, Greece
- Study coordinator: Vasileios Tzortzis, Professor
- Email: urologydpt.uth@gmail.com
- Phone: 00302413502811
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.