Clinical trial NCT02665312: Cardiotoxicity and Risk Factors in Patients With Colorectal Cancer Receiving Fluoropyrimidine
Official title: CHEmotherapy-induced Cardiotoxicity and Study of risK Factor Correlation in Patients With Colorectal Cancer Receiving Oral or INfusional Fluoropyrimidine Treatment - CHECKPOINT
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Keywords: cardiotoxicity
fluoropyrimidine
colorectal cancer
Lead sponsor: Fondazione del Piemonte per l'Oncologia
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with colorectal cancer receiving Oral or INfusional fluoropyrimidine Treatment

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.

Eligibility criteria: 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 )

Primary outcomes:
measure: Assessment of the incidence of cardiovascular events during the first three cycles of therapy with capecitabine or 5-FU
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alba
country: Italy
facility: Ospedale San Lazzaro - ASL CN 2 Alba Bra
state: Cuneo
city: Candiolo
country: Italy
facility: Fondazione del Piemonte per l' Oncologia - IRCCS Candiolo
state: Turin
city: Turin
country: Italy
facility: AO Ordine Mauriziano di Torino
city: Turin
country: Italy
facility: AOU Città della Salute e della Scienza di Torino - Presidio Molinette - Oncologia Medica 1
city: Turin
country: Italy
facility: AOU Città della Salute e della Scienza di Torino - Presidio Molinette - Oncologia Medica 2
city: Turin
country: Italy
facility: Ospedale Cottolengo
city: Turin
country: Italy
facility: Humanitas Gradenigo
city: Turin
country: Italy
facility: Ospedale San Giovanni Bosco - ASL TO2
Study officials:
affiliation: IRCCS Candiolo
name: Francesco Leone, MD
role: PRINCIPAL_INVESTIGATOR
References: