← Back to Search

Alkylating agents

Trifluridine/Tipiracil + Oxaliplatin for Esophageal Cancer

Phase 2

Waitlist Available

Led By Sarbjit Mukherjee, MD

Research Sponsored by Roswell Park Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

Must have potentially resectable disease

Must not have

Any concurrent active malignancy that requires active systemic intervention

Grade 2 or higher peripheral neuropathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from treatment until death due to any cause or last follow-up, assessed up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how well trifluridine/tipiracil and oxaliplatin work as the first line of treatment for patients with esophageal or gastroesophageal junction adenocarcinoma.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include fatigue, nausea, diarrhea, low blood cell counts leading to increased infection risk or bleeding problems, nerve damage causing numbness or tingling sensations (neuropathy), liver enzyme changes, and allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am fully active or can carry out light work.

Select...

My disease can possibly be removed with surgery.

Select...

I can swallow pills without any trouble.

Select...

My cancer has not spread to distant organs and is not deeply invasive.

Select...

My cancer is confirmed to be in the esophagus or where the stomach meets the esophagus.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have another cancer that needs treatment.

Select...

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

Select...

I have a genetic condition that affects how my body processes certain sugars.

Select...

I have had chemotherapy, radiotherapy, or surgery for esophageal cancer.

Select...

My cancer has spread to other parts of my body.

Select...

I have had a severe allergic reaction to oxaliplatin.

Select...

I have been treated with TAS 102 or am allergic to it or its ingredients.

Select...

I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from treatment until death due to any cause or last follow-up, assessed up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from treatment until death due to any cause or last follow-up, assessed up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from treatment until death due to any cause or last follow-up, assessed up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Patients With a Pathologic Complete Response

Secondary study objectives

Median Overall Survival

Median Progression Free Survival

Number of Patients With Grade 3 or Higher Treatment Related Adverse Events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trifluridine and Tipiracil Hydrochloride

2019

Completed Phase 2

~180

Oxaliplatin

2011

Completed Phase 4

~2890