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Feasibility of Switching Fluoropyrimidine Due to Cardiotoxicity Study

NCT04260269 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2024-12-12

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Tampere University Hospital

    collaborator OTHER

  • Helsinki University Central Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Denmark
  • Finland
  • Iceland
  • Ireland
  • Netherlands
  • Norway
  • Sweden

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04260269 on ClinicalTrials.gov