An Observational Study to Learn More About the Long-Term Responses to Treatment With Regorafenib in Patients With Metastatic Colorectal Cancer in the United States — COLONGER  

Metastatic Colorectal Cancer Clinical Trial

Official title: Real-world Study in Metastatic Colorectal Cancer Patients With Long-term Responses to Regorafenib in the US

Status Completed

Clinical Trial Summary

This is an observational study in which data already collected from patients 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) that has spread to other parts of the body.

The study drug, regorafenib, is already approved for cancer doctors to prescribe to patients with mCRC. It is an anti-cancer drug that blocks several proteins, called enzymes, which are involved in the growth of cancer.

The participants in this study were treated with regorafenib as part of their regular care from their doctors.

Some studies have shown that patients with mCRC who took regorafenib had improved survival outcomes, and some of them did well on the treatment for a long time. Cancer doctors have also reported from their routine practice that some patients with mCRC are able to respond to regorafenib for a longer period than others. However, there is limited knowledge about which people this is likely to happen for.

To better understand the long-term response of regorafenib treatment, there is a need for a large-scale study in the real world.

The main purpose of this study is to learn more about patients who showed a long-term response to regorafenib as a mono treatment for mCRC. To do this, researchers will collect the following information from the participants' health records:

Duration of treatment with regorafenib

Percentage of participants who received treatment with regorafenib for at least 5 months and 4 months.

Characteristics, including age, sex, race, health condition, and signs and symptoms of mCRC, of participants who received treatment with regorafenib for at least 5 months and 4 months.

The data will come from an electronic health records database called the Flatiron Health Data Repository for patients in the United States. The data will be from patients with mCRC who started treatment with regorafenib between July 2013 and December 2022.

Researchers will consider the data of the participants collected until May 2023.

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

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

• NCT number: NCT06029010
• Study type: Observational
• Source: Bayer
• Status: Completed
• Start date: August 31, 2023
• Completion date: October 31, 2023