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

NCT06358599 | Completed

• 1 other identifier: TUO-UR-21-01
• Study Type: observational
• Target: 221
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer; Bladder Cancer Stage I; Bladder Cancer Stage II

Keywords

bladder cancer; variant histology; neoadjuvant therapy; radical cystectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Neoadjuvant chemotherapy prior to radical cystectomy

Drug: Cisplatin

radical cystectomy directly

Interventions

Cisplatin DRUG

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

Also known as: neoadjuvant cisplatin containing combination chemotherapy

Neoadjuvant chemotherapy prior to radical cystectomy

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

multiple tertiary care clinics

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, 06170, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: April 10, 2024
• Study Start: January 7, 2021
• Primary Completion: October 20, 2023
• Study Completion: January 15, 2024
• Last Updated: April 10, 2024

Record last verified: 2024-04

Locations

TU (1)