NCT06029010Completed
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
Real-world Study in Metastatic Colorectal Cancer Patients With Long-term Responses to Regorafenib in the US
Source: ClinicalTrials.gov · Last updated 26 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 2326 (actual)
- First submitted
- 1 Sept 2023
- Start date
- 31 Aug 2023
- Primary completion date
- 27 Jan 2025
- Lead sponsor
- Bayer
- Diseases
- Colorectal cancer
- NCT number
- NCT06029010
What you commit to
- Study type: Observational
- Participants enrolled: 2326
- From 31 Aug 2023 to the primary completion date, 27 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Many Locations Coordinator of this site? Confirm its status | Multiple Locations | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.