An Observational Study Called STAR-T to Learn More About the Sequential Treatment With Regorafenib and TAS-102 in Adults With Metastatic Colorectal Cancer Under Real World Conditions
NCT ID: NCT05839951
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
818 participants
OBSERVATIONAL
2023-04-24
2025-04-30
Brief Summary
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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.
Regorafenib is an anti-cancer drug that blocks several proteins, called enzymes, which are involved in the growth of cancer. The combination of anti-cancer drugs trifluridine and tipiracil is called TAS-102. It prevents cancer cells from growing and multiplying.
Both regorafenib and TAS-102 are approved treatments for metastatic colorectal cancer and are available for doctors to prescribe to people with mCRC after previous lines of treatment have been unsuccessful.
Regorafenib and TAS-102 work in different ways and impact people differently. People might receive one of these drugs first and followed by the other. The best sequence for taking these drugs is still unclear.
Researchers have also found that TAS-102, when taken with another anti-cancer drug called bevacizumab, helps people live longer than when taken alone.
To better understand the impact of the sequence of taking regorafenib and TAS-102 (with or without bevacizumab), more knowledge is needed about how these work together in people with mCRC in real world settings.
The main purpose of this study is to learn more about the characteristics and impact of treatment in people with mCRC who received regorafenib and TAS-102 (with or without bevacizumab) one after the other. This information will be grouped based on their treatment sequence and age group (less or more than 65 years old).
In addition, the researchers want to learn about :
* how long participants were treated with regorafenib and TAS-102 taken one after the other in a sequential order,
* any treatment for mCRC that the participants received after the sequential treatment,
* any treatment received for a condition in which the bone marrow cannot make up enough blood cells (a common side effect of cancer treatment), during the sequential treatment,
* if and how often white blood cells that fight infection decreased during the sequential treatment,
* the number of hospital or testing facility visits that participants had during the sequential treatment, and
* how long did participants live (also called overall survival).
The participants in this study had already received regorafenib and TS-102 (with or without bevacizumab) as part of their regular care from their doctors.
The data will come from the participants' information stored in an electronic health records database called Flatiron mCRC EDM. Data collected will be from January 2015 to December 2022.
Researchers will only look at the health information from adults in the United States of America.
In this study, only available data from routine care is collected. No visits or tests will be required as part of this study.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Cohort T-R
Patients with mCRC who started with TAS+/-Bev first, followed by regorafenib, without other therapies in between.
TAS-102 (trifluridine and tipiracil, Lonsurf®)
Oral cytotoxic chemotherapy
Bevacizumab
VEGFR inhibitor
Cohort TAS+BEV
Patients with mCRC who received combo use of TAS+BEV.
Bevacizumab
VEGFR inhibitor
Cohort R-T
Patients with mCRC who started with regorafenib first, followed by TAS+/-Bev (Bevacizumab) without other therapies in between.
Regorafenib (BAY73-4506, Stivarga®)
Oral multitargeted kinase inhibitor
Bevacizumab
VEGFR inhibitor
Interventions
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Regorafenib (BAY73-4506, Stivarga®)
Oral multitargeted kinase inhibitor
TAS-102 (trifluridine and tipiracil, Lonsurf®)
Oral cytotoxic chemotherapy
Bevacizumab
VEGFR inhibitor
Eligibility Criteria
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Inclusion Criteria
* Received sequential treatment of regorafenib and TAS-102 (either mono or with bevacizumab) after mCRC diagnosis, with at least one documented clinical visit on or after treatment; OR
* Patients with mCRC who received combo use of TAS+BEV, with at least one documented clinical visit on or after treatment
Exclusion Criteria
* Patients involved in clinical trials during the study period (as indicated by the masked therapies)
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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Many locations
Whippany, New Jersey, United States
Countries
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Related Links
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Other Identifiers
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22386
Identifier Type: -
Identifier Source: org_study_id