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
1 other identifier
observational
200
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2016
Typical duration for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 23, 2016
CompletedFirst Posted
Study publicly available on registry
January 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedSeptember 23, 2016
September 1, 2016
2 years
January 23, 2016
September 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of the incidence of cardiovascular events during the first three cycles of therapy with capecitabine or 5-FU
24 months
Eligibility Criteria
Patients with colorectal cancer receiving Oral or INfusional fluoropyrimidine Treatment
You may qualify if:
- 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
You may not qualify if:
- 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 )
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Ospedale San Lazzaro - ASL CN 2 Alba Bra
Alba, Cuneo, 12051, Italy
Fondazione del Piemonte per l' Oncologia - IRCCS Candiolo
Candiolo, Turin, 10060, Italy
AO Ordine Mauriziano di Torino
Turin, Turin, 101028, Italy
AOU Città della Salute e della Scienza di Torino - Presidio Molinette - Oncologia Medica 1
Turin, Turin, 10126, Italy
AOU Città della Salute e della Scienza di Torino - Presidio Molinette - Oncologia Medica 2
Turin, Turin, 10126, Italy
Ospedale Cottolengo
Turin, Turin, 10152, Italy
Humanitas Gradenigo
Turin, Turin, 10153, Italy
Ospedale San Giovanni Bosco - ASL TO2
Turin, Turin, 10154, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francesco Leone, MD
IRCCS Candiolo
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2016
First Posted
January 27, 2016
Study Start
January 1, 2016
Primary Completion
January 1, 2018
Study Completion
January 1, 2019
Last Updated
September 23, 2016
Record last verified: 2016-09