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

April 9, 2024 updated by: Cagri Akpinar, Ankara Etlik City Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

221

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06170
        • Ankara Etlik City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

multiple tertiary care clinics

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Neoadjuvant chemotherapy prior to radical cystectomy
Drug: Cisplatin
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
Other Names:
  • neoadjuvant cisplatin containing combination chemotherapy
radical cystectomy directly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in survival outcomes at postoperative 2-year follow-up in patients with variant histology who received neoadjuvant chemotherapy before radical cystectomy.
Time Frame: 2 years from radical cystectomy surgery
2 years from radical cystectomy surgery

Secondary Outcome Measures

Outcome Measure
Time 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.
Time Frame: 2 years from radical cystectomy surgery
2 years from radical cystectomy surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Etlik City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2021

Primary Completion (Actual)

October 20, 2023

Study Completion (Actual)

January 15, 2024

Study Registration Dates

First Submitted

March 13, 2024

First Submitted That Met QC Criteria

April 9, 2024

First Posted (Estimated)

April 10, 2024

Study Record Updates

Last Update Posted (Estimated)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUO-UR-21-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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