An observational study in Solid Tumor, sponsored by Helsinki University Central Hospital. Enrolling by invitation at 13 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-12.
Sponsored by Helsinki University Central Hospital · Observational
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.
Fluoropyrimidine chemotherapy agents, such as 5-fluorouracil and capecitabine, are occasionally associated with cardiotoxicity that may manifest as chest pain, ECG alterations, cardiac arrhythmia, and rarely myocardial infarction and sudden death. Clinical fluoropyrimidine cardiotoxicity is infrequent (1-8% of patients), but subclinical toxicity may be much more common (up to one third of patients). The underlying mechanisms are not well understood, but they may include abnormal coronary artery contractility or spasm, and myocardial toxicity. Cardiotoxicity may be less frequent with S-1 (a combination of tegafur, gimeracil and oteracil at a molar ratio of 1:0.4:1) as compared with 5-fluorouracil and capecitabine, but head-to-head comparisons are lacking.
Anecdotal evidence suggests that patients who have cardiotoxicity on other fluoropyrimidines may be successfully treated with S-1. The purpose of this retrospective study is to compare different 5-fluorouracil-based dosing modalities and S-1, and compare cardiotoxicity during these treatments.
The patient population was treated for solid tumors with a 5-fluorouracil based regimen and had a cardiac event grade 1-4. All patients were re-challenged with a different fluoropyrimidine or S-1 and assessed for cardiotoxicity during re-challenge.
Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.
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All consecutive patients who fulfil the following inclusion criteria will be included in the database until the target number of patients has been included:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Also known as: S-1 / Teysuno, capecitabine, 5-fluorouracil, tegafur, trifluridine-tipiracil / Lonsurf
Recurrence of fluoropyrimidine related cardiac toxicity after switch to S-1 based treatment
Cardiac tolerability according to NCI-CTCAE following cardiotoxicity initiated switch of fluoropyrimidine to S-1
Time frame: After switch to and during one line of S-1 based chemotherapy (average 6 months)
Recurrence of fluoropyrimidine related cardiac toxicity after switch to any fluoropyrimidine
Cardiac tolerability according to NCI-CTCAE following cardiotoxicity initiated switch of fluoropyrimidine to another fluoropyrimidine chemotherapy
Time frame: After switch to and during one line of another fluoropyrimidine regimen (average 6 months)
Cardiac symptoms during fluoropyrimidine chemotherapy
Frequency and severity according to NCI-CTCAE of cardiac symptoms during different fluoropyrimidines and the correlation with other added cytotoxics or biologics
Time frame: During one line of fluoropyrimidine based chemotherapy (average 6 months)
Diagnostic work-up
Diagnostic work-up for cardiotoxicity in real world data
Time frame: During one line of fluoropyrimidine based chemotherapy (average 6 months)
Time-lines for cardiotoxicity
Time-lines for appearance of cardiotoxicity during fluoropyrimidine-based chemotherapy
Time frame: During one line of fluoropyrimidine based chemotherapy (average 6 months)
Dose-intensity
Dose-intensity of the therapy at the cycle causing cardiotoxicity
Time frame: During one cycle (average 3 weeks) of fluoropyrimidine-based chemotherapy causing cardiac toxicity
Alteration in cardiac functional parameters during fluoropyrimidine treatment induced cardiotoxicity
The alterations of (if evaluated), graded as normal, non-significant abnormalities or significant abnormalities.: * ECG abnormalities * Ejection fraction in % * Coronary artery status on angiogram * Cardiac arrhythmias in ECG, Holter or cardiac monitor registration * Plasma troponin concentration and other cardiac enzymes and other laboratory tests as within reference range ro abnormal * Serum alpha-fluoro-beta-alanine (FBAL) concentration
Time frame: During one cycle (average 3 weeks) of fluoropyrimidine-based chemotherapy causing cardiac toxicity
Plan to share: No
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