Study on Using Blood Tests to Guide Treatment for Advanced or Metastatic Colorectal Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT03844620

Provider View

This clinical trial is exploring how blood tests that detect tumor DNA can help guide treatment decisions for patients with advanced colorectal cancer. The study compares the effectiveness of two drugs, regorafenib and TAS-102, in managing cancer that has spread.

Patient Parameters

Program Overview

This phase II study is investigating whether blood tests that detect circulating tumor DNA (ctDNA) can help doctors decide on the best treatment for patients with advanced colorectal cancer that has spread to other parts of the body. The trial will compare the use of two drugs, regorafenib and TAS-102, which may help stop cancer cells from growing by blocking certain enzymes. Researchers aim to understand how well ctDNA testing works in guiding treatment decisions for these patients.

Description

The main goal of this study is to see if changes in tumor DNA found in the blood can predict how well the cancer is responding to treatment. Researchers will also look at the side effects of the treatments and how they affect patients' quality of life. The study will compare two groups of patients: one group will have their treatment guided by ctDNA testing, while the other group will receive standard care without ctDNA guidance.

Patients in the ctDNA group will have blood tests to check for tumor DNA and will receive either regorafenib, TAS-102, or a combination of both, depending on the test results. Treatment will continue every 28 days as long as it is effective and side effects are manageable.

Patients in the standard care group will receive either regorafenib or TAS-102 based on their doctor's recommendation. Treatment will continue if the cancer is stable or improving.

After finishing the study treatment, patients will have follow-up visits every month for up to 18 months to monitor their health and the cancer's response to treatment.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of colorectal cancer.
  • Have advanced or metastatic cancer with no curative options available.
  • Have cancer that can be measured by scans.
  • Have tried at least two previous treatments for metastatic colorectal cancer, including specific chemotherapy drugs, and either did not respond or cannot tolerate these treatments.
  • Be eligible to receive either regorafenib or TAS-102 as determined by their doctor.
  • Women of childbearing potential must have a negative pregnancy test within 14 days before starting the study and agree to use effective birth control during the study.
  • Be able to complete questionnaires with or without help.
  • Be willing to provide written consent to participate in the study.
  • Be willing to return to the study site for follow-up visits.
  • Be willing to provide blood samples for research purposes.
  • Not be pregnant or nursing, and agree to use contraception if of childbearing potential.
  • Not have any severe health conditions that would interfere with the study.

Exclusion Criteria

  • Have previously received TAS-102 but cannot take regorafenib, or vice versa.
  • Have severe heart conditions, such as recent heart failure or heart attack.
  • Have an ongoing severe infection.
  • Have untreated or unstable brain tumors.
  • Have kidney failure requiring dialysis.
  • Be unable to swallow pills.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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