22 Participants Needed

Trifluridine/Tipiracil + Oxaliplatin for Esophageal Cancer

Recruiting at 3 trial locations
AR
Overseen ByAsk Roswell
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Roswell Park Cancer Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

CF

Christos Fountilas, MD

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

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.
See 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.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Chemotherapy

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.

6 weeks
3 cycles, each with 1 visit (in-person)

Chemoradiation and Surgery

Patients undergo standard of care chemoradiation therapy followed by surgery.

Approximately 6 months after start of neoadjuvant therapy

Follow-up

Participants are monitored for safety and effectiveness after treatment

Every 3-6 months for years 1-2, then every 6-12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Oxaliplatin
  • Trifluridine and Tipiracil Hydrochloride
Trial Overview 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.
How Is the Trial Designed?
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:

πŸ‡ͺπŸ‡Ί
Approved in European Union as Eloxatin for:
  • Colorectal cancer
πŸ‡ΊπŸ‡Έ
Approved in United States as Eloxatin for:
  • Colorectal cancer
πŸ‡¨πŸ‡¦
Approved in Canada as Eloxatin for:
  • Colorectal cancer
πŸ‡―πŸ‡΅
Approved in Japan as Eloxatin for:
  • Colorectal cancer
πŸ‡¨πŸ‡­
Approved in Switzerland as Eloxatin for:
  • Colorectal cancer
πŸ‡¨πŸ‡³
Approved in China as Ai Heng for:
  • Colorectal cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials
427
Recruited
40,500+

National Comprehensive Cancer Network

Collaborator

Trials
121
Recruited
7,400+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of ServiceΒ·Privacy PolicyΒ·CookiesΒ·Security