Clinical trial · Interventional
Neoadjuvant Chemotherapy in Locally Advanced Bladder Cancer
Neoadjuvant Gemcitabine and Cisplatin in Locally Advanced Bladder Cancer
NCT01801644CI-TRIAL-00009614completedN/AClinicalTrials.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)
To evaluate the efficacy and safety of neoadjuvant gemcitabine and cisplatin (gem/cis) in locally advanced bladder cancer.
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 |
|---|---|---|---|
| gemcitabine plus cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- gemcitabine plus cisplatin
- description
- gemcitabine plus cisplatin: 3 cycles of gemcitabine 1000 mg/m2 on days 1,8,15 as a 30 minute infusion and cisplatin 70 mg/m2 on day 1 as an 2 hour infusion will be applied
- interventionNames
- Drug: gemcitabine plus cisplatin
Primary outcomes (1)
- measure
- pathologic response rate
- timeFrame
- at time of surgery
- description
- evaluation of the pathologic response rate after 3 cycles of neoadjuvant gemcitabine/cisplatin at time of radical cystectomy
Secondary outcomes (1)
- measure
- safety, number of participants with adverse events and grade of adverse events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age * histologically confirmed stage T2, T3 or T4a urothelial bladder cancer with N0-N2 * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * bone marrow reserve (neutrophil count \>1500 cells per μL,platelet count \>100 000 per μL) count * hepatic function (serum bilirubin \<2,5 times the upper limit of normal, serum aminotransferase ≤2,5 times the upper limit of normal). * renal function with a creatinine clearance \>60ml/min Exclusion Criteria: * metastatic disease * serious or uncontrolled concurrent medical illness * pregnancy * history of other malignancies (with the exception of excised cervical or basal skin or squamous-cell carcinoma) * non-transitional cell bladder cancer * creatinine clearance \<60ml/min
References
Publications (2)
- BACKGROUNDDash A, Pettus JA 4th, Herr HW, Bochner BH, Dalbagni G, Donat SM, Russo P, Boyle MG, Milowsky MI, Bajorin DF. A role for neoadjuvant gemcitabine plus cisplatin in muscle-invasive urothelial carcinoma of the bladder: a retrospective experience. Cancer. 2008 Nov 1;113(9):2471-7. doi: 10.1002/cncr.23848. PMID 18823036
- RESULTTolerability of neoadjuvant chemotherapy with gemcitabine plus cisplatin in elderly (older than age 65) patients (pts) with muscle-invasive urothelial cancer. D. Niedersuess-Beke, B. Gruenberger, T. Puntus, W. Bauer, M. Lamche, P. Schramek, J. G. Meran; Barmherzige Brueder Hospital, Vienna, Austria; Goettlicher Heiland Hospital, Vienna, Austria ´ J Clin Oncol 29: 2011 (suppl 7; abstr 296)