Clinical trial NCT05551039: 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
Official title: RegoFlex EU/Real World Evidence on Stivarga Flexible Dosing in Patients With Metastatic Colorectal Cancer in Europe
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Colorectal Cancer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2022-09-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.


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

Primary outcomes:
measure: Proportion of patients initiating a flexible regorafenib dose (40, 80, or 120 mg) versus 160 mg
timeFrame: 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)
measure: Dose at treatment end (last prescribed regorafenib dose): 40, 80, 120, or 160 mg
timeFrame: 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)
measure: Average dose intensity at first and subsequent cycles
timeFrame: 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)
measure: Time to first dose change
timeFrame: 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)
measure: Time to first full dose of 160 mg
timeFrame: 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)
measure: Number of cycles received
timeFrame: 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)
measure: Proportion of patients initiating 1, 2, 3, or more cycles
timeFrame: 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)
measure: Duration of treatment (DoT)
timeFrame: 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)
measure: Time to discontinuation (TTD)
timeFrame: 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)
measure: Proportion of patients with reasons for discontinuation
timeFrame: 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:
measure: Descriptive summary of demographics characteristics
timeFrame: 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)
measure: Descriptive summary of Stage of disease
timeFrame: 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)
measure: Descriptive summary of Eastern Cooperative Oncology Group (ECOG) performance status
timeFrame: 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)
measure: Descriptive summary of Primary tumor status
timeFrame: 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)
measure: Descriptive summary of Number of metastatic
timeFrame: 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)
measure: Descriptive summary of Site of metastasis
timeFrame: 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)
measure: Descriptive summary of K-RAS mutation status and N-RAS mutation status
timeFrame: 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)
measure: Descriptive summary of Line of therapy (LOT) for regorafenib
timeFrame: 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)
measure: Descriptive summary of Prior adjuvant treatment
timeFrame: 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)
measure: Descriptive summary of Treatments prior to index date, overall and by LOT
timeFrame: 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)
measure: Descriptive summary of Pre-existing comorbidities
timeFrame: 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)
Other outcomes:
Locations:
city: Whippany
country: United States
facility: Many locations
state: New Jersey
Study officials:
References: