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ENROLLING BY INVITATION
NCT04260269

Feasibility of Switching Fluoropyrimidine Due to Cardiotoxicity Study

Sponsor: Helsinki University Central Hospital

View on ClinicalTrials.gov

Summary

The purpose of the present study is to evaluate cardiotoxicity during re-challenge of a different modality of fluoropyrimidine (primary end-point S-1 and secondary any other fluoropyrimidine) after having perceived cardiotoxicity with a fluoropyrimidine based regimen previously. The patient population is being treated for solid tumors.

Official title: Feasibility of Switching Fluoropyrimidine Due to Cardiotoxicity in Patients with Solid Tumors: a Retrospective, International and Non-interventional Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2018-06-01

Completion Date

2027-12

Last Updated

2024-12-12

Healthy Volunteers

No

Conditions

Interventions

DRUG

Fluoropyrimidine

This is the assessment of a specific evaluation of cardiac safety for patients with solid tumors who have experienced cardiotoxicity grade 1-4 during treatment with a fluoropyrimidine based treatment and are re-challenged with a different fluoropyrimidine. This multicentre, retrospective database is built to assess the impact on the cardiac and global safety of two different fluoropyrimidine based treatment regimens, of which the first has caused cardiotoxicity grade 1-4. Cardiac data will be collected by medical record review from initiation of first fluoropyrimidine-based treatment and switch to second fluoropyrimidine-based treatment until death or last follow-up. Basic demographics, cancer and treatment information from the whole course of cancer until death or last follow-up.

Locations (13)

Odense University Hospital

Odense, Denmark

Department of Oncology

Tampere, Pirkanmaa, Finland

Helsinki University Central Hospital

Helsinki, Uusimaa, Finland

Oulu university hospital

Oulu, Finland

Turku university hospital

Turku, Finland

Landspitali

Reykjavik, Iceland

St. Vincents University Hospital

Dublin, Ireland

Academic Medical Center

Amsterdam, Netherlands

Haukeland University Hospital

Bergen, Norway

Skone university hospital

Lund, Sweden

Karolinska University Hospital

Stockholm, Sweden

Sundsvall hospital

Sundsvall, Sweden

Uppsala academic hospital

Uppsala, Sweden