Cardiotoxicity and Risk Factors in Patients With Colorectal Cancer Receiving Fluoropyrimidine

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

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

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Italy
  • Turin, Italy, 101028
    • Not yet recruiting
    • AO Ordine Mauriziano di Torino
    • Contact: Elisa Sperti, MD
  • Turin, Italy, 10126
    • Not yet recruiting
    • AOU Città della Salute e della Scienza di Torino - Presidio Molinette - Oncologia Medica 1
    • Contact: Patrizia Racca, MD
  • Turin, Italy, 10126
    • Not yet recruiting
    • AOU Città della Salute e della Scienza di Torino - Presidio Molinette - Oncologia Medica 2
    • Contact: Mario Airoldi, MD
  • Turin, Italy, 10152
    • Not yet recruiting
    • Ospedale Cottolengo
    • Contact: Alex Luca Gerbino, MD
  • Turin, Italy, 10153
    • Not yet recruiting
    • Humanitas Gradenigo
    • Contact: Alessandro Comandone, MD
  • Turin, Italy, 10154
    • Not yet recruiting
    • Ospedale San Giovanni Bosco - ASL TO2
    • Contact: Cristiano Oliva, MD
  • Cuneo
    • Alba, Cuneo, Italy, 12051
      • Not yet recruiting
      • Ospedale San Lazzaro - ASL CN 2 Alba Bra
      • Contact: Mario Franchini, MD
  • Turin
    • Candiolo, Turin, Italy, 10060
      • Recruiting
      • Fondazione del Piemonte per l' Oncologia - IRCCS Candiolo
      • Contact: Celeste Cagnazzo, PhD; Phone Number: 00390119933851; Email: celeste.cagnazzo@ircc.it
      • Principal Investigator: Francesco Leone, MD
      • Sub-Investigator: Alessandro Bonzano, MD
      • Sub-Investigator: Ilaria Depetris, MD
      • Sub-Investigator: Massimo Aglietta, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with colorectal cancer receiving Oral or INfusional fluoropyrimidine Treatment

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fondazione del Piemonte per l'Oncologia
• Investigators: Principal Investigator: Francesco Leone, MD, IRCCS Candiolo

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: January 23, 2016
• First Submitted That Met QC Criteria: January 23, 2016
• First Posted (Estimate): January 27, 2016

Study Record Updates

• Last Update Posted (Estimate): September 23, 2016
• Last Update Submitted That Met QC Criteria: September 22, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: colorectal cancer; cardiotoxicity; fluoropyrimidine
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Digestive System Diseases; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Neoplasms; Neoplasms by Site; Wounds and Injuries; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Colorectal Neoplasms; Cardiotoxicity
• Other Study ID Numbers: CheckPoint

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED