An observational study in Metastatic Colorectal Cancer, sponsored by Centre Oscar Lambret. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-13.
Sponsored by Centre Oscar Lambret · Observational
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 704 is above the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Centre Oscar Lambret is the lead sponsor of 127 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
elligible patients were those who accepted to participate to the cohort study, and whom physicians accepted to collaborate on the REBECCA cohort.
Exclusion criteria :
regorafenib for all groups
Also known as: stivarga
Overall survival (OS)
median time between the date of the first administration REG and the date of the death
Time frame: at death or at the end of study
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
Time frame: 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
Time frame: at the end of treatment
Compliance
dose-intensity of treatment with REG, including the actual daily dosage
Time frame: 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
Time frame: at the end of treatment
Potential predictive factors
regarding tolerance, time under REG treatment, PFS, and OS.
Time frame: 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
Time frame: at the end of study
Plan to share: No
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Centre Oscar Lambret