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The Impact of Neoadjuvant Chemotherapy on Survival Outcomes in Patients With Variant Histologies Bladder Cancer Who Underwent Radical Cystectomy

The Impact of Neoadjuvant Chemotherapy on Survival Outcomes in Patients With Variant Histologies Who Underwent Radical Cystectomy: A Multicenter Study of the Turkish Urooncology Association

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06358599
Enrollment
221
Registered
2024-04-10
Start date
2021-01-07
Completion date
2024-01-15
Last updated
2024-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer, Bladder Cancer Stage I, Bladder Cancer Stage II

Keywords

bladder cancer, variant histology, neoadjuvant therapy, radical cystectomy

Brief summary

The World Health Organization 2016 bladder tumor classification reported that the diagnosis of variant histology has increased from 6% to 33% in the last 2 decades, and there is an increasing interest in investigating the effects on disease management, treatment options, and survival outcomes in bladder tumors with variant histology. In bladder tumors, variant histology is known to be more aggressive and has a worse prognosis than pure urothelial cancer, and most cases are muscle invasive at diagnosis. Neoadjuvant cisplatin-containing combination chemotherapy is known to improves overall survival in patients with urothelial cancers. However, it is unclear whether patients with non-pure urothelial cancer (variant) histology will also benefit from neoadjuvant chemotherapy. The investigators aimed to evaluate the role of Neoadjuvant cisplatin-containing combination chemotherapy in the final treatment plan and its impact on survival in patients with bladder cancer who were diagnosed with variant histology in the radical cystectomy specimen.

Interventions

DRUGCisplatin

Neoadjuvant cisplatin-containing combination chemotherapy was defined as the receipt of multiagent systemic chemotherapy initiated within 6 months prior to the date of radical cystectomy

Sponsors

Ankara Etlik City Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Patients with squamous cell, micropapillary, nested variant, sarcomatoid, neuroendocrine, or plasmacytoid variant histology * Patients who were non-metastatic at diagnosis * Patients who completed staging and demographic data, * Patients with pathological stage (p)T2 or high grade pT1, clinical stage (c)N0 or cN1, and underwent radical cystectomy

Exclusion criteria

* Although RC histopathology was variant histology, patients in whom variant histology was not detected in previously transurethral resection bladder pathology * Patients who received therapies other than radical cystectomy (intravesical bacillus-calmette-guerin or chemotherapy) were excluded from the study. * Patients with a concomitant diagnosis of upper urinary tract urothelial carcinoma * Patients with histopathologically pure urothelial carcinoma

Design outcomes

Primary

MeasureTime frame
Change in survival outcomes at postoperative 2-year follow-up in patients with variant histology who received neoadjuvant chemotherapy before radical cystectomy.2 years from radical cystectomy surgery

Secondary

MeasureTime frame
Factors associated with worse survival outcomes in cox-regression analysis at 2-year follow-up of all patients with variant histology who underwent radical cystectomy.2 years from radical cystectomy surgery

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026