Metastatic Colorectal Cancer
Conditions
Keywords
regorafenib, cohort, metastatic colorectal cancer
Brief summary
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
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.
Interventions
DRUGregorafenib
regorafenib for all groups
Sponsors
Centre Oscar Lambret
Bayer
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | at death or at the end of study | median time between the date of the first administration REG and the date of the death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients and tumor baseline characteristics | at the end of treatment | 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 |
| Time under REG treatment | at the end of 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 |
| Compliance | at the end of study | dose-intensity of treatment with REG, including the actual daily dosage |
| Safety of REG | at the end of treatment | according to NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) v4.0 and within some subgroups of patients |
| Potential predictive factors | at the end of study | regarding tolerance, time under REG treatment, PFS, and OS. |
| Progression-free survival (PFS) | at the end of study | median time between the date of the first administration REG and the date of the first progression |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORAntoine ADENIS, MD
Centre Oscar Lambret
Outcome results
None listed