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

NCT05551039 | Completed

• 1 other identifier: 22124
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (10)

• Proportion of patients initiating a flexible regorafenib dose (40, 80, or 120 mg) versus 160 mg

  Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)

• Dose at treatment end (last prescribed regorafenib dose): 40, 80, 120, or 160 mg

  Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)

• Average dose intensity at first and subsequent cycles

  The sum of dose strength (mg) will be divided by the days on therapy in each cycle.

  Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)

• Time to first dose change

  Time to first dose change: time (months) from date of initial regorafenib dose to 1st dose increase/decrease among patients initiating a flexible regorafenib dose (40, 80, or 120 mg)

  Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)

• Time to first full dose of 160 mg

  Time to 1st full dose of 160 mg: time (months) from date of initial regorafenib dose to 1st full dose of 160 mg during the treatment history among patients with 40, 80, or 120 mg initial dose, overall and by initial dose.

  Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)

• Number of cycles received

  Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)

• Proportion of patients initiating 1, 2, 3, or more cycles

  The label recommended regorafenib treatment cycle is 28 days.

  Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)

• Duration of treatment (DoT)

  Duration of treatment: time (months) from date of initial regorafenib dose to date of last dose prior to a \>2-week gap during the follow up period.

  Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)

• Time to discontinuation (TTD)

  Time to discontinuation: time (months) from date of initial regorafenib dose to date of discontinuation (as indicated by CRF)

  Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)

• Proportion of patients with reasons for discontinuation

  Reasons for discontinuation includes: distant progression/relapse, local progression/relapse, patient choice to discontinue therapy, poor performance status, side effects, new primary malignancy, death, lost to follow up, coronavirus disease 2019 (COVID-19)-related and other.

  Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)

Secondary Outcomes (11)

• Descriptive summary of demographics characteristics

  Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)

• Descriptive summary of Stage of disease

  Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)

• Descriptive summary of Eastern Cooperative Oncology Group (ECOG) performance status

  Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)

• Descriptive summary of Primary tumor status

  Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)

• Descriptive summary of Number of metastatic

  Retrospective analysis from 01-Jan-2019 up to 30-Apr-2022 (or up until 3 months prior to date of data collection, whichever occurs latest)

Study Arms (1)

Physicians treating patients with mCRC

Physicians provide case histories of mCRC patients

Other: Retrospective patient chart review

Interventions

Retrospective patient chart review 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).

Physicians treating patients with mCRC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with mCRC in France, Italy and Belgium and initiated regorafenib therapy between January 1, 2019 and December 31, 2021

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many locations

Whippany, New Jersey, 07981, United States

Location

Related Links

• Click here to find information for studies related to Bayer products. To find this study enter the NCT number or Bayer Study ID in the search field.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: September 22, 2022
• Study Start: August 15, 2022
• Primary Completion: January 15, 2023
• Study Completion: January 15, 2023
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)