Clinical trial · Observational
Neoadjuvant Chemotherapy in Non Muscle Invasive T1b Bladder Cancer
Role of Neoadjuvant Chemotherapy in the Conservative Management of Non-muscle Invasive Bladder Cancer (NMIBC) T1b
NCT04245618CI-TRIAL-00043089unknownClinicalTrials.gov clinicaltrialsProvenance
- 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)
The aim of our study is to evaluate the benefit of NAC in T1b NMIBC .
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| neoadjuvant chemotherapy ( cisplatin - gemcitabine) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Evaluation of the benefit of NAC in T1b NMIBC .
- timeFrame
- baseline
- description
- assessment of the response in correlation with high risk features.
Secondary outcomes (1)
- measure
- Overall survival (OS) and disease-specific survival (DSS).
- timeFrame
- 2 years
- description
- Overall survival (OS) and disease-specific survival (DSS).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient who are older than 18 years old. 2. Histologically confirmed to have Non-muscle invasive bladder cancer, T1bN0M0 ,clinically and radiologically confirmed to have bladder cancer. 3. Patient should have Eastern Cooperative Oncology Group performances status (ECOG)0-1 with adequate hematologic, hepatic and renal functions including hemoglobin\>10 /dl, absolute neutrophil count ≥1,500/mm3, platelets ≥100,000/mm3, serum bilirubin \<2 mg/dl ,both Alanine transaminase( ALT) and aspartate aminotransferase( AST) ≤2× upper limit of normal (ULN), alkaline phosphates ≤5×ULN,and serum creatinine ≤1.5 mg/dl or creatinine clearance ≥60 ml/min. Exclusion Criteria: 1. Patients with radiographic evidence of nodal or distant metastases. 2. A past history of upper tract disease, neuroendocrine features. 3. Non-cisplatin-based NAC . 4. Prior radiation therapy to their pelvis. 5. A palpable three-dimensional mass on EUA. 6. Known to be stage 0, T1a, II, III, IV. 7. Active serious infection, or a psychiatric illness that would preclude obtaining informed consent or history of cardiac disease will be excluded.
References
Publications (8)
- BACKGROUNDCambier S, Sylvester RJ, Collette L, Gontero P, Brausi MA, van Andel G, Kirkels WJ, Silva FC, Oosterlinck W, Prescott S, Kirkali Z, Powell PH, de Reijke TM, Turkeri L, Collette S, Oddens J. EORTC Nomograms and Risk Groups for Predicting Recurrence, Progression, and Disease-specific and Overall Survival in Non-Muscle-invasive Stage Ta-T1 Urothelial Bladder Cancer Patients Treated with 1-3 Years of Maintenance Bacillus Calmette-Guerin. Eur Urol. 2016 Jan;69(1):60-9. doi: 10.1016/j.eururo.2015.06.045. Epub 2015 Jul 23. PMID 26210894
- BACKGROUNDTarin TV, Power NE, Ehdaie B, Sfakianos JP, Silberstein JL, Savage CJ, Sjoberg D, Dalbagni G, Bochner BH. Lymph node-positive bladder cancer treated with radical cystectomy and lymphadenectomy: effect of the level of node positivity. Eur Urol. 2012 May;61(5):1025-30. doi: 10.1016/j.eururo.2012.01.049. Epub 2012 Feb 7. PMID 22342773
- BACKGROUNDChahal R, Harrison SC. Re: an interval longer than 12 weeks between the diagnosis of muscle invasion and cystectomy is associated with worse outcome in bladder carcinoma. J Urol. 2003 Oct;170(4 Pt 1):1327; author reply 1327. No abstract available. PMID 14515867
- BACKGROUNDBlack PC, Brown GA, Dinney CP. The impact of variant histology on the outcome of bladder cancer treated with curative intent. Urol Oncol. 2009 Jan-Feb;27(1):3-7. doi: 10.1016/j.urolonc.2007.07.010. Epub 2008 Jan 14. PMID 18367107
- BACKGROUNDOtto W, van Rhijn BW, Breyer J, Bertz S, Eckstein M, Mayr R, Lausenmeyer EM, Denzinger S, Burger M, Hartmann A. Infiltrative lamina propria invasion pattern as an independent predictor for cancer-specific and overall survival of instillation treatment-naive stage T1 high-grade urothelial bladder cancer. Int J Urol. 2018 May;25(5):442-449. doi: 10.1111/iju.13532. Epub 2018 Feb 22. PMID 29473226
- BACKGROUNDBabjuk M, Burger M, Comperat EM, Gontero P, Mostafid AH, Palou J, van Rhijn BWG, Roupret M, Shariat SF, Sylvester R, Zigeuner R, Capoun O, Cohen D, Escrig JLD, Hernandez V, Peyronnet B, Seisen T, Soukup V. European Association of Urology Guidelines on Non-muscle-invasive Bladder Cancer (TaT1 and Carcinoma In Situ) - 2019 Update. Eur Urol. 2019 Nov;76(5):639-657. doi: 10.1016/j.eururo.2019.08.016. Epub 2019 Aug 20.