Cardiotoxicity and Risk Factors in Patients With Colorectal Cancer Receiving Fluoropyrimidine

• Conditions: Colorectal Cancer

• Registration Number: NCT02665312
• Lead Sponsor: Fondazione del Piemonte per l'Oncologia

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-23
• Study First Submitted QC: 2016-01-23
• Study First Posted: 2016-01-27
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-22
• Last Update Posted: 2016-09-23
• Primary Completion: 2018-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 )

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of the incidence of cardiovascular events during the first three cycles of therapy with capecitabine or 5-FU	24 months

Trial Locations

Locations (8)

Ospedale Cottolengo; 🇮🇹 Turin, Italy

AOU Città della Salute e della Scienza di Torino - Presidio Molinette - Oncologia Medica 1; 🇮🇹 Turin, Italy

Fondazione del Piemonte per l' Oncologia - IRCCS Candiolo; 🇮🇹 Candiolo, Turin, Italy

AOU Città della Salute e della Scienza di Torino - Presidio Molinette - Oncologia Medica 2; 🇮🇹 Turin, Italy

AO Ordine Mauriziano di Torino; 🇮🇹 Turin, Italy

Humanitas Gradenigo; 🇮🇹 Turin, Italy

Ospedale San Giovanni Bosco - ASL TO2; 🇮🇹 Turin, Italy

Ospedale San Lazzaro - ASL CN 2 Alba Bra; 🇮🇹 Alba, Cuneo, Italy