Study of TAS-102 and Radiation Therapy for Treating Liver Metastases from Colorectal Cancer

Sponsor: Massachusetts General Hospital

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03223779

Provider View

This clinical trial is exploring a combination of the drug TAS-102 and radiation therapy to treat liver metastases in patients with colorectal cancer. The study aims to find the safest and most effective dose of this combination treatment.

Patient Parameters

Program Overview

This study is testing a new treatment approach for patients with liver metastases from colorectal cancer. It combines a drug called TAS-102 with radiation therapy. The goal is to determine the safest and most effective dose of TAS-102 when used with radiation. TAS-102 works by stopping cancer cells from growing, and radiation helps kill cancer cells while protecting normal cells. The study is in its early phases, focusing on safety and dosage.

Description

This clinical trial is in Phase I/II, which means it is in the early stages of testing. The study is looking at the safety and best dose of a drug called Trifluridine (TAS-102) when used with radiation therapy for treating liver metastases from colorectal cancer. Trifluridine is already approved by the FDA for treating this type of cancer, but its combination with radiation therapy is still being studied.

The study involves patients who have liver metastases from colorectal cancer. Trifluridine works by stopping the DNA replication in cancer cells, which may prevent them from growing. Radiation therapy helps to kill cancer cells while protecting normal tissue. Research suggests that Trifluridine may make radiation more effective.

Participants will receive the combination of TAS-102 and radiation therapy, and researchers will monitor them to determine the safest and most effective dose.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of colorectal cancer with 1-4 liver metastases.
  • Must have at least 800 mL of healthy liver tissue.
  • Can have other stable cancer outside the liver if the main cancer is in the liver and referred for liver radiation.
  • Must have measurable cancer that can be tracked by scans.
  • Can have had previous treatments like chemotherapy or surgery, but not liver-directed radiation.
  • Must be 18 years or older.
  • Must have an expected survival of more than three months.
  • Must have a good performance status (ECOG 0 or 1).
  • Must have liver metastases that cannot be removed by surgery.
  • Must have normal organ and bone marrow function as shown by specific blood tests.
  • If having cirrhosis, must be in Child-Pugh Group A.
  • Must agree to use effective birth control during and after the study.
  • Must be able to understand and sign a consent form.
  • Must be able to take oral medications.

Exclusion Criteria

  • Women who are pregnant or breastfeeding.
  • Have large amounts of fluid in the abdomen or brain issues.
  • Have conditions that reduce tolerance to radiation.
  • Have had previous liver radiation treatment.
  • Have a serious illness that limits survival to less than three months.
  • Have had recent chemotherapy or radiation therapy within the last three weeks.
  • Are taking other investigational drugs or cancer treatments during the study.
  • Have uncontrolled illnesses like infections or heart problems.
  • Have previously received TAS-102.

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