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

NCT ID: NCT05551039

Last Updated: 2023-01-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-15
• Study Completion Date: 2023-01-15

Brief 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.

Conditions

Metastatic Colorectal Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Physicians treating patients with mCRC

Physicians provide case histories of mCRC patients

Retrospective patient chart review

Intervention Type: OTHER

Retrospective patient chart review to be completed by mCRC-treating physicians. Data is collected through an online case report form (CRF); physicians provide case histories of mCRC patients who initiated regorafenib treatment in most recent 3 years (2019-2021).

Interventions

Retrospective patient chart review

Retrospective patient chart review to be completed by mCRC-treating physicians. Data is collected through an online case report form (CRF); physicians provide case histories of mCRC patients who initiated regorafenib treatment in most recent 3 years (2019-2021).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with a histopathological or cytological diagnosis of colorectal cancer and metastatic disease (stages IVA, IVB, or IVC)
• Patients must have initiated regorafenib as monotherapy, regardless of line of therapy, from January 1, 2019 to December 31, 2021 (or up until 3 months prior to date of data collection, whichever occurs latest)
• Aged ≥18 years at index date

Exclusion Criteria

• Patients with regorafenib treatment prior to January 1, 2019
• Patients who have participated in a clinical trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Many locations

Whippany, New Jersey, United States

Countries

United States

Related Links

https://clinicaltrials.bayer.com/

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Other Identifiers

22124

Identifier Type: -

Identifier Source: org_study_id