Cardiotoxicity and Risk Factors in Patients With Colorectal Cancer Receiving Fluoropyrimidine

Colorectal Cancer Clinical Trial

Official title:

CHEmotherapy-induced Cardiotoxicity and Study of risK Factor Correlation in Patients With Colorectal Cancer Receiving Oral or INfusional Fluoropyrimidine Treatment - CHECKPOINT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02665312
• Other study ID #: CheckPoint
• Status: Recruiting
• Phase: N/A
• First received: January 23, 2016
• Last updated: September 22, 2016
• Start date: January 2016
• Est. completion date: January 2019

Study information

• Verified date: September 2016
• Source: Fondazione del Piemonte per l'Oncologia
• Contact: Celeste Cagnazzo, PhD
• Phone: 00390119933851
• Email: celeste.cagnazzo[@]ircc.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2019
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiotoxicity
• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
Italy	Ospedale San Lazzaro - ASL CN 2 Alba Bra	Alba	Cuneo
Italy	Fondazione del Piemonte per l' Oncologia - IRCCS Candiolo	Candiolo	Turin
Italy	AO Ordine Mauriziano di Torino	Turin
Italy	AOU Città della Salute e della Scienza di Torino - Presidio Molinette - Oncologia Medica 1	Turin
Italy	AOU Città della Salute e della Scienza di Torino - Presidio Molinette - Oncologia Medica 2	Turin
Italy	Humanitas Gradenigo	Turin
Italy	Ospedale Cottolengo	Turin
Italy	Ospedale San Giovanni Bosco - ASL TO2	Turin

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione del Piemonte per l'Oncologia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the incidence of cardiovascular events during the first three cycles of therapy with capecitabine or 5-FU		24 months	No