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

Metastatic Colorectal Cancer Clinical Trial

— REBECCA  

Official title:

REBECCA: A Cohort Study of Regorafenib in the Real-life Setting in Patients Previously Treated for Metastatic Colorectal Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02310477
• Other study ID #: REBECCA-1305
• Status: Completed
• Phase: N/A
• First received: October 8, 2014
• Last updated: August 8, 2016
• Start date: February 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2016
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: National Consultative Ethics Committee for Health and Life SciencesFrance: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 704
• Est. completion date: December 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• regorafenib
regorafenib for all groups

Locations

Country	Name	City	State
France	Centre Oscar Lambret	Lille

Sponsors (2)

Lead Sponsor	Collaborator
Centre Oscar Lambret	Bayer

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	median time between the date of the first administration REG and the date of the death	at death or at the end of study	No
Secondary	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	at the end of treatment	No
Secondary	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	at the end of treatment	No
Secondary	Compliance	dose-intensity of treatment with REG, including the actual daily dosage	at the end of study	No
Secondary	Safety of REG	according to NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) v4.0 and within some subgroups of patients	at the end of treatment	Yes
Secondary	Potential predictive factors	regarding tolerance, time under REG treatment, PFS, and OS.	at the end of study	No
Secondary	Progression-free survival (PFS)	median time between the date of the first administration REG and the date of the first progression	at the end of study	No