A Real-World Study to Learn More About the Order of Different Treatments and Their Effects in People With Metastatic Colorectal Cancer Receiving Their Third and Fourth Line of Treatment — RegoSeq  

Metastatic Colorectal Cancer Clinical Trial

Official title: Real-world Sequence of Systemic Therapies and Outcomes in Patients With Metastatic Colorectal Cancer Receiving 3rd and 4th Line of Treatment.

Status Active, not recruiting

Clinical Trial Summary

This is an observational study in which data already collected from people with metastatic colorectal cancer will be studied.

Metastatic colorectal cancer (mCRC) is a cancer of the colon (large bowel) or the rectum (lowest part of the bowel just before the anus). Cancer is considered metastatic if it spreads to other parts of the body.

The study drug, regorafenib, is already approved for doctors to prescribe to people with mCRC. It is an anti-cancer drug that blocks several proteins, called enzymes, which are involved in the growth of cancer. Other approved treatments for mCRC include TAS and bevacizumab. The combination of the anti-cancer drugs trifluridine and tipiracil is called TAS. Both TAS and bevacizumab prevent cancer cells from growing and multiplying.

Some studies have shown that people with mCRC who took TAS along with bevacizumab, lived longer than when TAS was taken alone. This may be especially beneficial for patients who have tried other treatments before. However, there is limited knowledge about how and in which order these drugs are given.

To better understand the impact of the order of taking regorafenib and TAS, with or without bevacizumab, more knowledge is needed about how well these treatments work in people with mCRC in European countries.

The main purpose of this study is to learn more about the effects of treatment in people with mCRC who have already received regorafenib and TAS, with or without bevacizumab, one after the other (also called sequential treatment) in a different order.

To do this, researchers will collect the following information:

• how long participants received sequential treatment for mCRC

• number of participants receiving further treatment for mCRC after the sequential treatment

• number and type of further treatments for mCRC

• how long did participants live (also called overall survival).

The data will come from the participants' information stored in health records from 4 centers in 3 European countries including France, Italy, and Spain. The data will be from people with mCRC who started sequential treatment between January 2013 and December 2022 or until the most recent date that allows researchers to assess the participants' health for at least 3 months.

In this study, only available data from routine care are collected. No visits or tests will be required as part of this study.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

• NCT number: NCT06137170
• Study type: Observational
• Source: Bayer
• Status: Active, not recruiting
• Start date: March 1, 2024
• Completion date: November 29, 2024