An Observational Study, Called RegoFlex EU, to Learn More About the Use of Stivarga at Reduced Doses as Recommended (Flexible Dosing) to Treat People With Metastatic Colorectal Cancer in Real World Settings in Europe — RegoFlex EU  

Metastatic Colorectal Cancer Clinical Trial

Official title: RegoFlex EU/Real World Evidence on Stivarga Flexible Dosing in Patients With Metastatic Colorectal Cancer in Europe

Status Completed

Clinical Trial Summary

This is an observational study in which data from patients with metastatic colorectal cancer in three European countries who received STIVARGA® (regorafenib), are collected. In observational studies, only observations are made without specified advice or interventions.

Metastatic colorectal cancer (mCRC) is a cancer that starts in the large bowel or the rectum (the lowest part of the gut) and has spread to other parts of the body. Regorafenib is an anti-cancer drug that blocks several proteins called enzymes, which are involved in the development and growth of cancer. A wide range of such enzymes called tyrosine kinases are targeted.

In 2013, regorafenib was approved in Europe for doctors to prescribe to people with mCRC who have previously been treated or cannot receive other available treatments. It is known that doctors may change/reduce the amount (the dose) of regorafenib they give (flexible dosing), so that the patients better tolerate the treatment. However, little information is available on the doses of regorafenib given in France, Italy, and Belgium in usual practice.

In this study researchers want to learn more about how and in which amount regorafenib is usually given to patients with mCRC in France, Italy, and Belgium:

• at the beginning

• during, and

• at the end of the regorafenib therapy.

In addition, the study team will collect data about/if:

• the treatment duration at each treatment dose of regorafenib,

• the number of people who received reduced initial dosing of regorafenib in real word settings in France, Italy, and Belgium,

• reduced (flexible) initial dosing of regorafenib allows patients to stay longer on treatment.

To answer these questions, the researchers will look back at cases that have already happened when the study begins. The data will be collected through an online case report form. The doctors will provide case histories of mCRC patients who started regorafenib treatment in most recent 3 years and 4 months (from January 1, 2019 to Apr 30, 2022) or up until 3 months prior to the date of data collection.

Besides this data collection, no further tests or examinations are planned in this study.

There are no required visits or tests in this study.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

• NCT number: NCT05551039
• Study type: Observational
• Source: Bayer
• Status: Completed
• Start date: August 15, 2022
• Completion date: January 15, 2023