NCT04947059 Effectiveness of an Immediate Postoperative Intravesical Instillation With Either Gemcitabine or Epirubicin in Patients With Urinary Bladder Cancer (Gemcitabine Epirubicin Normal SAline)
| NCT ID | NCT04947059 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Thessaly |
| Condition | Bladder Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2021-12-14 |
| Primary Completion | 2025-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 180 participants in total. It began in 2021-12-14 with a primary completion date of 2025-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Vasileios Tzortzis, Professor
PRINCIPAL INVESTIGATOR
Urology Department, University of Thessaly, University Hospital of Larissa, Greece
Frequently Asked Questions
Who can join the NCT04947059 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04947059 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 180 participants.
Is NCT04947059 currently recruiting?
Yes, NCT04947059 is actively recruiting participants. Contact the research team at urologydpt.uth@gmail.com for enrollment information.
Where is the NCT04947059 trial being conducted?
This trial is being conducted at Larissa, Greece.
Who is sponsoring the NCT04947059 clinical trial?
NCT04947059 is sponsored by University of Thessaly. The principal investigator is Vasileios Tzortzis, Professor at Urology Department, University of Thessaly, University Hospital of Larissa, Greece. The trial plans to enroll 180 participants.
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