Regorafenib in Metastatic Colorectal Cancer : a Cohort Study in the Real-life Setting (REBECCA)
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|ClinicalTrials.gov Identifier: NCT02310477|
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : August 9, 2016
|Condition or disease||Intervention/treatment|
|Metastatic Colorectal Cancer||Drug: regorafenib|
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.
|Study Type :||Observational|
|Actual Enrollment :||704 participants|
|Official Title:||REBECCA: A Cohort Study of Regorafenib in the Real-life Setting in Patients Previously Treated for Metastatic Colorectal Cancer.|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||December 2014|
- Drug: regorafenib
regorafenib for all groupsOther Name: stivarga
- Overall survival (OS) [ Time Frame: at death or at the end of study ]median time between the date of the first administration REG and the date of the death
- Patients and tumor baseline characteristics [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: at the end of study ]dose-intensity of treatment with REG, including the actual daily dosage
- Safety of REG [ Time Frame: 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 [ Time Frame: at the end of study ]regarding tolerance, time under REG treatment, PFS, and OS.
- Progression-free survival (PFS) [ Time Frame: at the end of study ]median time between the date of the first administration REG and the date of the first progression
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310477
|Centre Oscar Lambret|
|Lille, France, 59020|
|Principal Investigator:||Antoine ADENIS, MD||Centre Oscar Lambret|