Clinical trial NCT02310477: Regorafenib in Metastatic Colorectal Cancer : a Cohort Study in the Real-life Setting
Official title: REBECCA: A Cohort Study of Regorafenib in the Real-life Setting in Patients Previously Treated for Metastatic Colorectal Cancer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Colorectal Cancer
Keywords: regorafenib, cohort, metastatic colorectal cancer
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2014-12-08
Enrollment: 704
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival (OS)
timeFrame: at death or at the end of study
Secondary outcomes:
measure: Patients and tumor baseline characteristics
timeFrame: at the end of treatment
measure: Time under REG treatment
timeFrame: at the end of treatment
measure: Compliance
timeFrame: at the end of study
measure: Safety of REG
timeFrame: at the end of treatment
measure: Potential predictive factors
timeFrame: at the end of study
measure: Progression-free survival (PFS)
timeFrame: at the end of study
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Oscar Lambret
Study officials:
affiliation: Centre Oscar Lambret
name: Antoine ADENIS, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Adenis A, de la Fouchardiere C, Paule B, Burtin P, Tougeron D, Wallet J, Dourthe LM, Etienne PL, Mineur L, Clisant S, Phelip JM, Kramar A, Andre T. Survival, safety, and prognostic factors for outcome with Regorafenib in patients with metastatic colorectal cancer refractory to standard therapies: results from a multicenter study (REBECCA) nested within a compassionate use program. BMC Cancer. 2016 Jul 7;16:412. doi: 10.1186/s12885-016-2440-9.