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NCT05839951 · ClinicalTrials.gov registry record
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
A clinical trial, sponsored by Bayer.
- Completed
- Registry status
- 818
- Enrollment target
NCT05839951 is a clinical trial that has completed, run by Bayer. The registered enrollment target is 818 participants.
The verdict
NCT05839951 has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- 818 participants
- Enrollment target
Study Summary
This is an observational study using data that has been collected from participants who received their usual treatments. 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 canno
Interventions
- DRUG Bevacizumab
- DRUG Regorafenib (BAY73-4506, Stivarga®)
- DRUG TAS-102 (trifluridine and tipiracil, Lonsurf®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 818 participants |
| Start Date | 2023-04-24 |
| Est. Completion | 2025-04-30 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05839951
The ClinicalTrials.gov registry entry for NCT05839951 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 818 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Bevacizumab is the first listed.
NCT05839951 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05839951 about?
NCT05839951 is a clinical study titled "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". This is an observational study using data that has been collected from participants who received their usual treatments. 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 bod...
What is the current status of trial NCT05839951?
This trial is currently completed. The enrollment target is 818 participants. The study started on 2023-04-24. Estimated completion is 2025-04-30.
What interventions are being tested in trial NCT05839951?
The interventions under investigation include: Bevacizumab (DRUG), Regorafenib (BAY73-4506, Stivarga®) (DRUG), TAS-102 (trifluridine and tipiracil, Lonsurf®) (DRUG).
Who is sponsoring clinical trial NCT05839951?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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