Clinical trial NCT06029010: 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
Official title: Real-world Study in Metastatic Colorectal Cancer Patients With Long-term Responses to Regorafenib in the US
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Colorectal Cancer
Keywords: mCRC
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2023-09-08
Enrollment: 2326
Sex: MALE
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: Data for the study will be obtained from the Flatiron Health Data Repository; an electronic health record (EHR)-derived longitudinal demographically and geographically diverse database of oncology patients in routine clinical practice in the US.

Patients with mCRC who initiated regorafenib treatment between 1 JUL 2013 and 31 DEC 2022 will be followed through the electronic data from the start of regorafenib treatment until the date of death for patients who died, and the date of last visit on or up to 31 MAY 2023 for patients with no record of death.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of mCRC between 1 JAN 2013 and 31 DEC 2022 who initiated regorafenib monotherapy up to 14 days prior or after mCRC diagnosis and during the patient selection period (1 JUL 2013 to 31 DEC 2022).
* Adult patients (≥18 years old) at index date (date of first regorafenib treatment).
* Patients with at least one recorded visit, laboratory test, or other recorded electronic medical record (EMR) entry (e.g., treatment) in the Flatiron network at least 3 months prior to the index date, unless the patient was diagnosed with mCRC within the last 3 months.

Exclusion Criteria:

* Patients who had a diagnosis or recorded history of gastrointestinal stromal tumor (GISC), hepatocellular cancer (HCC), or other primary cancers (except non-melanoma skin cancers) during the 6-month period on or prior to the index date.
* For analyses of long-term responders, patients will be excluded if treatment duration \<5 and \<4 months for treatment completers, or treatment duration \<5 and \<4 months at last visit date for non-completers.

Primary outcomes:
measure: Duration of treatment with regorafenib monotherapy in patients who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥5 months
timeFrame: Retrospective analysis from 01-Jan-2013 to 31-May-2023
measure: Demographic characteristics of patients who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥5 months
timeFrame: Retrospective analysis from 01-Jan-2013 to 31-May-2023
measure: Descriptive analysis of clinical characteristics of patients who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥5 months
timeFrame: Retrospective analysis from 01-Jan-2013 to 31-May-2023
measure: Descriptive analysis of biomarkers of patients with mCRC who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥5 months
timeFrame: Retrospective analysis from 01-Jan-2013 to 31-May-2023
Secondary outcomes:
measure: Duration of treatment with regorafenib monotherapy in patients who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥4 months
timeFrame: Retrospective analysis from 01-Jan-2013 to 31-May-2023
measure: Demographic characteristics of patients who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥4 months
timeFrame: Retrospective analysis from 01-Jan-2013 to 31-May-2023
measure: Descriptive analysis of clinical characteristics of patients who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥4 months
timeFrame: Retrospective analysis from 01-Jan-2013 to 31-May-2023
measure: Descriptive analysis of biomarkers of patients with mCRC who had a long-term response to regorafenib monotherapy, as indicated by a treatment duration of ≥4 months
timeFrame: Retrospective analysis from 01-Jan-2013 to 31-May-2023
Other outcomes:
Locations:
city: Multiple Locations
country: United States
facility: Many Locations
state: New Jersey
Study officials:
References: