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

Completed

• Conditions: Bladder Cancer Stage II; Bladder Cancer; Bladder Cancer Stage I
• Interventions: Drug: Cisplatin

• Registration Number: NCT06358599
• Lead Sponsor: Ankara Etlik City Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-07
• Primary Completion: 2023-10-20
• Study Completion: 2024-01-15
• Study First Submitted: 2024-03-13
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-09
• Last Update Submitted: 2024-04-09
• Study First Posted: 2024-04-10
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 221

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neoadjuvant chemotherapy prior to radical cystectomy	Cisplatin	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Ankara Etlik City Hospital; 🇹🇷 Ankara, Turkey