Clinical trial · Interventional
Transurethral Resection of Bladder Tumor (TURBT) Combined With Adjuvant Intravenous GC Chemotherapy for Non-muscle-invasive Bladder Cancer
Prospective Cohort Study of Transurethral Resection of Bladder Tumor (TURBT) Combined With Adjuvant Intravenous GC Chemotherapy to Prevent Moderate-high Recurrence and Progression Risks of Muscle-invasive Bladder Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
It is still a challenge for urologic surgeon to prevent the post transurethral resection of bladder tumor (TURBT) recurrence of moderate-high risk non-muscle invasive bladder tumor. Adjuvant chemotherapy is a standard treatment for local progressive bladder tumor, which contains mainstream GC treatment scheme. It is common to observe clinically moderate-high risk NMIBC recurrence after routine intravesical instillation.Systematic chemotherapy can eliminate remained tumor cells especially those from mucosa basal cells so as to improve the prognosis of patients. Our clinical trial aims to investigate whether the utilization of combination of GC treatment scheme and epirubicin instillation would decrease the recurrence of moderate-high risk NMIBC.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Epirubicin Instillation | — | UNRESOLVED | — |
| Gemcitabine and Cisplatin Chemotherapy | — | UNRESOLVED | — |
| Prognosis | — | UNRESOLVED | — |
| Recurrence | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine, cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Monotherapy
- description
- Barely epirubicin was instilled after TURBT. Epirubicin was immediately instilled in 24h after TURBT. Instillation was conducted regularly for a year: once in a week for 8 times, once in two weeks for 8 times, once in a month for 6 times.
- type
- EXPERIMENTAL
- label
- Combination
- description
- Patients who were pathologically confirmed as moderate-high risk NMIBC. Epirubicin was immediately instilled in 24h after TURBT and regularly conducted for a year. Intervention: GC scheme systematic chemotherapy was underwent 5 days after TURBT, which contained gemcitabine 1000-1200mg/m2. Cisplatin (70mg/m2) was intravenous dripped in the first and 8th day after TURBT. Intravenous rehydration was conducted in the second day.
- interventionNames
- Drug: Gemcitabine, cisplatin
Primary outcomes (2)
- measure
- Tumor progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. moderate-high risk non-muscle invasive bladder cancer patients: Multiple,recurrent, II-III grade, tumor diameter\>3cm, invasive to submucosa, associated with carcinoma in situ. 2. Normal liver and renal function. Exclusion Criteria: 1. Liver and renal function deficiency (GFR\<60ml/min\*kg, ALT、AST\>1.5\*normal), lung function deficiency, heart failure, acute myocardial infarction, severe infection and trauma, major surgery and clinical hypotension and anaerobic conditions. 2. Attending other drug experiments. 3. Performance status, Zubrod-ECOG-WHO, ZPS≥2. 4. Pregnant. 5. Bone marrow transplantation, severe leukopenia, associated with severe infection or injury.
References
Publications (3)
- RESULTBabjuk M, Oosterlinck W, Sylvester R, Kaasinen E, Bohle A, Palou-Redorta J, Roupret M; European Association of Urology (EAU). EAU guidelines on non-muscle-invasive urothelial carcinoma of the bladder, the 2011 update. Eur Urol. 2011 Jun;59(6):997-1008. doi: 10.1016/j.eururo.2011.03.017. Epub 2011 Mar 22. PMID 21458150
- RESULTSylvester RJ, Oosterlinck W, Holmang S, Sydes MR, Birtle A, Gudjonsson S, De Nunzio C, Okamura K, Kaasinen E, Solsona E, Ali-El-Dein B, Tatar CA, Inman BA, N'Dow J, Oddens JR, Babjuk M. Systematic Review and Individual Patient Data Meta-analysis of Randomized Trials Comparing a Single Immediate Instillation of Chemotherapy After Transurethral Resection with Transurethral Resection Alone in Patients with Stage pTa-pT1 Urothelial Carcinoma of the Bladder: Which Patients Benefit from the Instillation? Eur Urol. 2016 Feb;69(2):231-44. doi: 10.1016/j.eururo.2015.05.050. Epub 2015 Jun 16. PMID 26091833
- RESULTVillavicencio H, Rodriguez Faba O, Palou J, Gausa L, Algaba F, Marcuello E. Bladder preservation strategy based on combined therapy in patients with muscle-invasive bladder cancer: management and results at long-term follow-up. Urol Int. 2010;85(3):281-6. doi: 10.1159/000316076. Epub 2010 Jul 30. PMID 20689253