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

Completed

• Conditions: Metastatic Colorectal Cancer

• Registration Number: NCT02310477
• Lead Sponsor: Centre Oscar Lambret

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.

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2014-10
• Study First Submitted: 2014-10-08
• Study Completion: 2014-12
• Study First Submitted QC: 2014-12-04
• Study First Posted: 2014-12-08
• Status Verified: 2016-01
• Last Update Submitted: 2016-08-08
• Last Update Posted: 2016-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 704

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.

Trial Locations

Locations (1)

Centre Oscar Lambret; 🇫🇷 Lille, France