Regorafenib in Metastatic Colorectal Cancer : a Cohort Study in the Real-life Setting

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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REBECCA: A Cohort Study of Regorafenib in the Real-life Setting in Patients Previously Treated for Metastatic Colorectal Cancer.

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Drug: regorafenib


Participation Criteria
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Eligibility Criteria
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Inclusion criteria : Patient ≥ 18 years old With a colorectal cancer metastatic histologically proven Have met the criteria defined in the monograph ATU (Temporary Authorization for Use) validated by French Health Authorities and for which the request for access to treatment has been validated, that is in patients with mCRC as used in clinical practice for mCRC who have been previously treated with, or are not considered candidates for, available therapies. Patients who received at least one dose on REG Exclusion criteria : Opposed to the study Patient does not meet the inclusion criteria Patient deprived of liberty or under guardianship

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: regorafenib|regorafenib for all groups|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival (OS) | median time between the date of the first administration REG and the date of the death | at death or at the end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients and tumor baseline characteristics | Tumor location, KRAS status, synchronous or metachronus metastases, time elapsed from diagnosis of metastases, surgery of the primary, previous times of treatment, weight/height/BMI, ECOG, met location, age, performance status | at the end of treatment | 
| Time under REG treatment | calculated from the start of treatment until the treatment discontinuation for any cause) and within some subgroups of patients:Tumor location, KRAS status, synchronous or metachronus metastases, time elapsed from diagnosis of metastases, surgery of the primary, previous times of treatment, weight/height/BMI, ECOG, met location, age, performance status, initial REG dosage | at the end of treatment | 
| Compliance | dose-intensity of treatment with REG, including the actual daily dosage | at the end of study | 
| Safety of REG | according to NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) v4.0 and within some subgroups of patients | at the end of treatment | 
| Potential predictive factors | regarding tolerance, time under REG treatment, PFS, and OS. | at the end of study | 
| Progression-free survival (PFS) | median time between the date of the first administration REG and the date of the first progression | at the end of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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regorafenib, cohort, metastatic colorectal cancer