Cardiotoxicity and Risk Factors in Patients With Colorectal Cancer Receiving Fluoropyrimidine

Fondazione del Piemonte per l'Oncologia200 enrolled

Overview

observational prospective study, designed for patients with colorectal cancer receiving for the first time 5-FU or capecitabine, with or without other chemotherapy combinations.

All patients enrolled will be evaluated for cardiovascular risk factors and, if resulted at cardiovascular risk, they will be submitted to cardiac examination and therapy optimization before starting chemotherapy. Patients will be evaluated with 12-lead ECG and blood sample for TnI and NT pro-BNP before start chemotherapy and on day 3 of chemotherapy during the first, second and third cycle. All patients developing cardiovascular events will be submitted to blood sample for TnI, NT-proBNP, hsTnI and cardiac examination.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Colorectal Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Signed written informed consent * Age ≥ 18 years * Histologically confirmed adenocarcinoma of colon or rectum (any T, any N, any M) receiving for the first time 5-FU or capecitabine, with or without other chemotherapy combinations Exclusion Criteria: * Prior treatment with fluoropyrimidines * Prior or concurrent chest radiotherapy * Any prior or concurrent treatment with cardiotoxic drug * Any serious or uncontrolled cardiovascular disease (defined by the specialist during cardiac examination, see section 6.3.2 for details )

Locations (8)

Ospedale San Lazzaro - ASL CN 2 Alba Bra

Alba, Cuneo, Italy

NOT_YET_RECRUITING

Fondazione del Piemonte per l' Oncologia - IRCCS Candiolo

Candiolo, Turin, Italy

RECRUITING

AO Ordine Mauriziano di Torino

Outcomes

Primary Outcomes

Assessment of the incidence of cardiovascular events during the first three cycles of therapy with capecitabine or 5-FU

Time frame: 24 months

Central Contacts

Celeste Cagnazzo, PhD

CONTACT

00390119933851 celeste.cagnazzo@ircc.it

Data from ClinicalTrials.gov

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