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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 October 2016 |
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Main ID: |
NCT02665312 |
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Date of registration:
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23/01/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cardiotoxicity and Risk Factors in Patients With Colorectal Cancer Receiving Fluoropyrimidine
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Scientific title:
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CHEmotherapy-induced Cardiotoxicity and Study of risK Factor Correlation in Patients With Colorectal Cancer Receiving Oral or INfusional Fluoropyrimidine Treatment - CHECKPOINT |
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Date of first enrolment:
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January 2016 |
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Target sample size:
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200 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02665312 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Italy
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Contacts
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Name:
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Celeste Cagnazzo, PhD |
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Address:
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Telephone:
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00390119933851 |
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Email:
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celeste.cagnazzo@ircc.it |
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Affiliation:
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Name:
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Francesco Leone, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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IRCCS Candiolo |
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Key inclusion & exclusion criteria
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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 )
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Colorectal Cancer
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Primary Outcome(s)
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Assessment of the incidence of cardiovascular events during the first three cycles of therapy with capecitabine or 5-FU
[Time Frame: 24 months]
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Secondary ID(s)
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CheckPoint
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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