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NCT Number: NCT07339878

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

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.

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Key information

Conditions

Metastatic Urothelial Carcinoma Carcinoma Carcinoma, Transitional Cell Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service Oncologie Médicale - CHU de Strasbourg - France

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Fabien Moinard Butot, MD

SUB_INVESTIGATOR

Philippe Barthélémy, MD

CONTACT

[email protected]

33 3 88 12 76 70

Philippe Barthélémy, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Description of the clinical characteristics of patients recently treated with first-line metastatic therapy for urothelial carcinoma

    Time frame: Up to 12 months

Study contacts

Contact information is provided by the study sponsor or research team.

Philippe Barthélémy, MD

CONTACT

[email protected]

33 3 88 12 76 70

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: FLORAL

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2026
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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