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ctDNA Testing for Colorectal Cancer
Study Summary
This trialstudies how well ctDNA testing works to guide treatment for advanced colorectal cancer using regorafenib or TAS-102. Blood samples will be used to understand how well patients respond.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 1 & 2 trial • 495 Patients • NCT02024607Trial Design
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Who is running the clinical trial?
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- I can understand and sign the consent form.I have not had serious heart issues like severe heart failure or a recent heart attack.I am not pregnant, nursing, or if capable of childbearing, I am using effective contraception.I do not have a serious ongoing infection.I have brain or meningeal tumors but have been stable for over 3 months after treatment.I have had at least 2 treatments for my colorectal cancer and either did not respond well or cannot tolerate more.My disease is advanced and cannot be cured with treatment.I cannot swallow pills.My colorectal cancer diagnosis was confirmed through lab tests.My doctor has approved me for regorafenib or TAS-102 treatment.I am not pregnant and agree to use birth control during the study.I can take regorafenib even if I've had TAS-102 before.I am willing to go back to the study center for follow-ups as required.I need dialysis for my kidney failure.
- Group 1: Arm II (SOC)
- Group 2: Arm I (ctDNA testing, regorafenib, TAS-102)
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Could you shed some light on the potential risks of taking Regorafenib?
"Regorafenib's safety has been evaluated, therefore receiving a rating of 2. This is because the Phase 2 trial only has limited data to support its effectiveness and safety."
What objectives are the researchers attempting to achieve through this investigation?
"This clinical trial will track the primary outcome of Treatment-related adverse events (TRAEs) over a 4 month post treatment period. Secondary outcomes, such as Hospitalizations/emergency room visits or need for medical interventions like blood transfusions and IV hydration, Median time to PRO deterioration and Median time to performance status deterioration will also be studied in comparison between arms."
What other research projects have been conducted involving Regorafenib?
"Currently, there are 96 studies exploring the efficacy of regorafenib with 8 in their concluding phase. Various sites across Lakewood, New jersey and beyond have been enlisted to undertake these experiments; 1,356 locations total."
Does this clinical trial still accept patients for participation?
"The clinical trial, which was first announced on the 29th of January 2019 and recently updated in late November 2022, is actively looking for participants. Data hosted on clinicialtrials.gov corroborates this fact."
Is this a cutting-edge clinical trial?
"As of now, there are 96 studies ongoing to assess the efficacy of regorafenib in 457 cities and 31 different countries. The initial research on this drug was conducted by Bayer in 2014, comprising 38 participants who completed Phase 2 approval trials. Subsequently, 340 more trials have been successfully finalized since then."
How many individuals are partaking in this trial?
"Affirmative. clinicaltrials.gov attests that this trial is currently enrolling patients, with the original post being published on January 29th 2019 and a recent update having been made in November 30th 2022. A total of 100 subjects are needed to participate at 1 site."
To what purposes is Regorafenib usually prescribed?
"Regorafenib is commonly administered to patients who have previously received oxaliplatin chemotherapy, anti-vegf therapies, sorafenib treatments, or are facing metastatic colorectal cancer (CRC)."
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