TAS-102 + Radiation for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This research study is studying a drug in combination with radiation therapy as a possible treatment for hepatic metastases from colorectal cancer.The interventions involved in this study are:* Trifluridine (TAS-102)* Radiation Therapy
Who Is on the Research Team?
Theodore S. Hong, MD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
Adults with colorectal cancer that has spread to the liver (1-4 metastases) and is inoperable due to location, fitness, or additional disease outside the liver. Participants should have stable extrahepatic disease for 3 months, measurable disease by CT scan, no prior liver radiation but may have had other treatments if more than 3 weeks ago. They must be physically able to take oral medication and not pregnant or breastfeeding.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Trifluridine (TAS-102) in combination with radiation therapy. TAS-102 dosing occurs on days 1 through 5 and 8 through 12, with radiation therapy administered concurrently.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of ctDNA levels and local control.
Long-term Follow-up
Participants are monitored for progression-free survival and overall survival, with assessments every 6 months for two years or until death.
What Are the Treatments Tested in This Trial?
Interventions
- Photon SBRT
- TAS-102
TAS-102 is already approved in United States, European Union, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Taiho Oncology, Inc.
Industry Sponsor
Tim Whitten
Taiho Oncology, Inc.
Chief Executive Officer since 2018
MBA and Pharmacy degree
Harold Keer
Taiho Oncology, Inc.
Chief Medical Officer
MD, PhD