Trifluridine/Tipiracil + Oxaliplatin for Esophageal Cancer

No longer recruiting at 3 trial locations

Overseen By Ask Roswell

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Roswell Park Cancer Institute

Disqualifiers: Metastatic disease, Active malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether two chemotherapy drugs, trifluridine/tipiracil and oxaliplatin, can effectively treat esophageal or gastroesophageal junction adenocarcinoma that can be surgically removed. These drugs aim to stop cancer cells from growing, dividing, or spreading. The trial seeks individuals diagnosed with esophageal cancer that has not spread and can potentially be removed by surgery. Participants should not have received prior chemotherapy or surgery for their esophageal tumor. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that trifluridine/tipiracil and oxaliplatin are generally well-tolerated when used together. In previous studies, patients experienced side effects that were mostly manageable and expected with chemotherapy, such as nausea, tiredness, and low blood cell counts. These side effects are common and usually not severe. Some patients might experience more serious effects, but these are less common.

The trifluridine/tipiracil combination has been studied for other types of cancer, and its safety profile remains consistent. This means the side effects are predictable and similar across different studies. Oxaliplatin is also a well-known chemotherapy drug with a safety record from its use in other cancers. Overall, the combination of these drugs has a safety record similar to other chemotherapy treatments. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for esophageal cancer?

Researchers are excited about the combination of Trifluridine/Tipiracil with Oxaliplatin for esophageal cancer because it offers a fresh approach to tackling this challenging condition. Unlike the standard treatment options that often rely on classic chemotherapy agents like 5-fluorouracil and cisplatin, this combination introduces Trifluridine/Tipiracil, which works by disrupting cancer cell division in a new way. Oxaliplatin adds another layer of effectiveness by damaging the DNA of cancer cells, making them more vulnerable to attack. This dual mechanism holds promise for more effective cancer control with potentially fewer side effects, providing new hope for patients.

What evidence suggests that trifluridine/tipiracil and oxaliplatin might be an effective treatment for esophageal cancer?

This trial studies the combination of trifluridine/tipiracil and oxaliplatin as an initial treatment for esophageal cancer. Studies have shown that this combination can effectively shrink tumors before other treatments like surgery. Research indicates that trifluridine/tipiracil is already approved for advanced stomach or gastroesophageal cancer, which is similar to esophageal cancer, as it stops cancer cells from growing and spreading. Early findings suggest that adding oxaliplatin might enhance its effectiveness. The trial aims to determine if this combination can serve as a strong first step in treating esophageal cancer that can be surgically removed. ^{2 3 5 6 7}

Who Is on the Research Team?

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.

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.

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?

Group I: Treatment (TAS-102, oxaliplatin) Experimental Treatment 2 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:

• Colorectal cancer

Approved in United States as Eloxatin for:

• Colorectal cancer

Approved in Canada as Eloxatin for:

• Colorectal cancer

Approved in Japan as Eloxatin for:

• Colorectal cancer

Approved in Switzerland as Eloxatin for:

• Colorectal cancer

Approved in China as Ai Heng for:

• Colorectal cancer

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11978735/

Trifluridine/Tipiracil and Oxaliplatin as Induction ... We evaluated a novel combination of trifluridine/tipiracil with oxaliplatin as induction chemotherapy (IC) followed by CRT.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04097028

NCT04097028 | Use of Trifluridine/Tipiracil and Oxaliplatin ... This phase II trial studies how well trifluridine/tipiracil and oxaliplatin work as the first line of treatment (induction) in treating patients with ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/cam4.70835

Trifluridine/Tipiracil and Oxaliplatin as Induction ... A randomized Phase III study evaluated the efficacy of trifluridine/tipiracil in refractory advanced gastric or GEJ cancer, showing that ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40200573/

Trifluridine/Tipiracil and Oxaliplatin as Induction ... We evaluated a novel combination of trifluridine/tipiracil with oxaliplatin as induction chemotherapy (IC) followed by CRT.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1590865824007333

Trifluridine/tipiracil + oxaliplatin ± nivolumab vs FOLFOX ± ... FTD/TPI is now approved in third-line treatment of patients with refractory metastatic gastroesophageal adenocarcinoma [14]. It has also already been evaluated ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11067808/

Efficacy and Safety of Trifluridine/Tipiracil-Containing ... We performed a systematic literature review to identify and summarize data from studies reporting clinical efficacy and safety outcomes for ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2059702922002678

Pooled safety analysis from phase III studies of trifluridine ... These results support FTD/TPI as a well-tolerated treatment in patients with mGC/GEJC or mCRC, with a consistent safety profile.