TAS-102 + Radiation for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to treat liver metastases from colorectal cancer by combining TAS-102 (Trifluridine/tipiracil hydrochloride mixture, or Lonsurf) with radiation therapy. The goal is to determine if this combination can more effectively target and treat liver cancer. It suits individuals diagnosed with colorectal cancer who have up to four liver metastases and have not previously received liver-directed radiation. Participants should maintain stable health and be able to take oral medications. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking cancer treatment research.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot be on any other investigational agents or anti-cancer therapy during the study.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that TAS-102, the drug under study in this trial, is generally well-tolerated by patients. Earlier studies reported common side effects such as fatigue and other mild issues. About 33.5% of patients experienced serious side effects, but only 8.8% were directly linked to the drug.
TAS-102 has already received approval for use in certain cancer treatments, suggesting its safety for patients. Since this trial is in the early stages (Phase 1/2), it primarily focuses on ensuring the treatment's safety. However, initial data offers some reassurance about its tolerability.12345Why do researchers think this study treatment might be promising for colorectal cancer?
Unlike the standard treatments for colorectal cancer, such as chemotherapy and targeted therapies, TAS-102 combines an innovative oral chemotherapy approach with radiation. TAS-102 is unique because it involves a combination of two active ingredients, trifluridine and tipiracil, which work together to interfere with cancer cell growth more effectively. Researchers are particularly excited about this treatment because it is administered alongside photon radiation therapy, aiming to enhance the overall effectiveness by targeting the cancer cells more precisely. This combination approach may offer improved outcomes for patients by potentially increasing the cancer's sensitivity to treatment while reducing side effects compared to traditional methods.
What evidence suggests that TAS-102 combined with radiation therapy could be an effective treatment for colorectal cancer?
Research has shown that TAS-102, also known as trifluridine/tipiracil, may help treat metastatic colorectal cancer, which is cancer that has spread. Studies found that patients taking TAS-102 lived longer and experienced a delay in cancer progression compared to those who did not take the drug. Real-world evidence suggests that TAS-102 works well when combined with other treatments, such as bevacizumab, enhancing its effectiveness. In this trial, participants will receive TAS-102 alongside Photon SBRT radiation therapy, which aims to directly target and kill cancer cells. Patients have generally tolerated taking TAS-102 every two weeks well, which helps reduce side effects while maintaining effectiveness. These findings support TAS-102 as a possible option for treating liver metastases from colorectal cancer.12367
Who Is on the Research Team?
Jennifer Y. Wo, 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:
- Metastatic colorectal cancer
- Metastatic colorectal cancer
- Metastatic colorectal cancer
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