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Recruiting NCT07339878

Criteria for Selecting First-line Metastatic Treatment for Patients With Urothelial Carcinoma

Observational Metastatic Urothelial Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Metastatic Urothelial Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Criteria for Selecting First-line Metastatic Treatment for Patients With Urothelial Carcinoma: Observational, Multicenter, Real-world Study

Overview

The standard first-line treatment for metastatic urothelial carcinoma has become the combination of Enfortumab Vedotin and Pembrolizumab following the publication of the EV-302 study results at the end of 2024. Another standard remains in 2025 for patients who are not eligible for the EV Pembrolizumab combination, namely platinum-based chemotherapy +/- avelumab in cases of non-progression. The objective of the FLORAL study is to determine the characteristics of these patients and the reasons that led clinicians to prefer a first-line treatment based on platinum salts.

Primary outcome measures

  • Description of the clinical characteristics of patients recently treated with first-line metastatic therapy for urothelial carcinoma [Time frame: Up to 12 months]

Eligibility criteria

Inclusion criteria

  • Patients over 18 years of age
  • Metastatic urothelial carcinoma
  • Treated with first-line metastatic therapy since October 2024

Exclusion criteria

  • Patient who expressed opposition to participating in the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 1 center
  • Service Oncologie Médicale - CHU de Strasbourg - France — Strasbourg

Identifiers

NCT: NCT07339878 · 9770

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗