Trifluridine/Tipiracil + Oxaliplatin for Esophageal Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen bySarbjit Mukherjee, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Roswell Park Cancer Institute

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This phase II trial studies how well trifluridine/tipiracil and oxaliplatin work as the first line of treatment (induction) in treating patients with esophageal or gastroesophageal junction adenocarcinoma that can be removed by surgery (resectable). Drugs used in chemotherapy, such as trifluridine/tipiracil and oxaliplatin, 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.

Eligibility Criteria

This trial is for adults with a specific type of cancer in the esophagus or where it meets the stomach, which can still be surgically removed. They should not have had previous treatments for this cancer and must be generally healthy with good organ function. Participants need to understand the study and agree to use effective birth control if they can have children.

Inclusion Criteria

Hemoglobin >= 9 g/dL

Creatinine < 1.5 upper limit of normal (ULN)

I am fully active or can carry out light work.

+10 more

Exclusion Criteria

I have another cancer that needs treatment.

I haven't had major surgery or significant radiation in the last 4 weeks and have recovered from any previous treatments.

I have moderate to severe numbness, pain, or weakness in my hands or feet.

+10 more

Participant Groups

The trial tests trifluridine/tipiracil combined with oxaliplatin as initial chemotherapy for patients. It aims to see how well these drugs work together in stopping tumor growth before surgery by killing cancer cells or preventing them from dividing and spreading.

1Treatment groups

Experimental Treatment

Group I: Treatment (TAS-102, oxaliplatin)Experimental Treatment2 Interventions

Patients receive oxaliplatin IV over 2 hours on day 1 and trifluridine and tipiracil hydrochloride PO BID on days 1-5. Treatment repeats every 14 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care chemoradiation therapy followed by surgery.

Oxaliplatin is already approved in European Union, United States, Canada, Japan, Switzerland, China for the following indications:

🇪🇺 Approved in European Union as Eloxatin for: