Metastatic Colorectal Cancer Clinical Trial
Official title:
REBECCA: A Cohort Study of Regorafenib in the Real-life Setting in Patients Previously Treated for Metastatic Colorectal Cancer.
This is a largest cohort study aimed to estimate the overall survival of patients been treated with regorafenib for metastatic colorectal cancer (mCRC) within the frame of a french compassionate program.
Regorafenib (REG) is a multi-kinase inhibitor with survival benefits in patients with
pretreated mCRC, as demonstrated in the phase III CORRECT study. As a result, REG has been
made available for medical practice use in the US, and in the Europe. However, prescribing
conditions in the real-life setting are known to be less stringent than selection criteria
in clinical trials. The REgorafeniB in mEtastatic Colorectal cancer: a French Compassionate
progrAm (REBECCA) is an ambispective cohort study designed to elucidate safety and
effectiveness outcomes associated with REG as used in clinical practice for mCRC who have
been previously treated with, or are not considered candidates for, available therapies.
Patients were identified from the database of the French ATU (Temporary Authorization for
Use), approved by the French Health Authorities to provide early access to innovative, not
yet approved medicinal products such as REG.
Baseline patient and tumor characteristics, REG dosing and dose-intensity, REG-related
adverse events, pre- and post REG treatments, predictors of events, and effectiveness data
(PFS, OS) were collected from patients who agreed, and whom physicians accepted to
collaborate on the REBECCA cohort.
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Observational Model: Cohort
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