TAS-102 + Radiation for Rectal Cancer

Recruiting in Palo Alto (17 mi)

Overseen byCharles D Lopez, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: OHSU Knight Cancer Institute

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?This phase 1b trial studies the side effects and best dose of TAS-102 when given together with radiation therapy in treating patients with stage II-III rectal cancer that has not been treated and can be removed by surgery (resectable). Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. This study is being done to find out the safest dose of TAS-102 that can be used with radiation treatment for rectal cancer.

Eligibility Criteria

This trial is for adults with stage II-III rectal cancer that hasn't spread, can be surgically removed, and who haven't had prior treatments. Participants must have good organ function, no serious infections or recent heart issues, and not be pregnant or breastfeeding. They should agree to use contraception and be able to take oral meds.

Inclusion Criteria

I am scheduled for specific chemotherapy that needs a central line.

I agree to use effective birth control during and for 6 months after the study.

My condition is a type of rectal cancer called adenocarcinoma.

+19 more

Exclusion Criteria

I am not pregnant or breast-feeding.

I have had blood clots or am on stable blood thinner medication.

I have not had any cancer except for certain skin cancers or cervical cancer in situ in the last 5 years.

+19 more

Participant Groups

The study tests the safety and best dose of TAS-102 chemotherapy combined with radiation therapy (either intensity-modulated or 3-dimensional conformal) in patients with resectable rectal cancer. The goal is to find out how well this combo works before surgery.

1Treatment groups

Experimental Treatment

Group I: Treatment (TAS-102, IMRT, 3D-CRT)Experimental Treatment3 Interventions

Patients receive TAS-102 PO BID Monday-Friday on weeks 1, 3, and 5. Patients also undergo IMRT or 3D-CRT 5 days per week on weeks 1-5. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care FOLFOX or CAPOX.

Trifluridine and Tipiracil Hydrochloride is already approved in United States, Japan, European Union for the following indications:

🇺🇸 Approved in United States as Lonsurf for: