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Alkylating agents

Trifluridine/Tipiracil + Oxaliplatin for Esophageal Cancer

Q: Could you elucidate on other research initiatives exploring Trifluridine and Tipiracil Hydrochloride?

Presently, there are a total of 378 active clinical trials looking into Trifluridine and Tipiracil Hydrochloride with 126 in the advanced Phase 3 stage. Most investigations for this drug combination originate from Woolloongabba, Queensland; however, 14181 locations around the world have Trifluridine and Tipiracil Hydrochloride <a href="https://www.withpower.com/clinical-trials/experimental">experimental</a> studies underway.

Q: Is the enrollment period for this trial still active?

Data hosted on clinicaltrials.gov reveals that the enrollment for this particular study has been concluded; it was first posted in December 20th 2019, and last edited November 22nd 2022. However, there are still over 1300 other trials actively seeking participants at present.

Q: How is Trifluridine and Tipiracil Hydrochloride customarily applied?

Patients previously treated with oxaliplatin chemotherapy, anti-vegf medication, and diagnosed with stage III <a href="https://www.withpower.com/clinical-trials/colon-cancer">colon cancer</a> can benefit from Trifluridine and Tipiracil Hydrochloride therapy.

Q: How extensive is the population participating in this clinical experiment?

At the present moment, this medical trial is not recruiting. It was first published on December 20th 2019 and recently edited November 22nd 2022. For those seeking alternative studies, 957 clinical trials are currently searching for patients with pathologic stage iva esophageal adenocarcinoma ajcc v8 while 378 trials require participants who meet criteria concerning Trifluridine and Tipiracil Hydrochloride treatments.

Q: Has the Food and Drug Administration given its stamp of approval to Trifluridine and Tipiracil Hydrochloride?

Our assessment in Power put trifluridine and tipiracil hydrochloride's safety at a 2 due to the Phase 2 trial status, indicating there is some proof of its security but none affirming its efficacy.

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

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

Study 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.Check my eligibility

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.See study design

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

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I am fully active or can carry out light work.

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My disease can possibly be removed with surgery.

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I can swallow pills without any trouble.

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

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Patients With a Pathologic Complete Response

Secondary outcome measures

Median Overall Survival

Median Progression Free Survival

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

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

~70

Oxaliplatin

2011

Completed Phase 4

~2560

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Comprehensive Cancer NetworkNETWORK

115 Previous Clinical Trials

7,613 Total Patients Enrolled

Roswell Park Cancer InstituteLead Sponsor

402 Previous Clinical Trials

30,836 Total Patients Enrolled

Sarbjit Mukherjee, MDPrincipal InvestigatorRoswell Park Cancer Institute

Media Library

Oxaliplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04097028 — Phase 2

Esophageal Adenocarcinoma Research Study Groups: Treatment (TAS-102, oxaliplatin)

Esophageal Adenocarcinoma Clinical Trial 2023: Oxaliplatin Highlights & Side Effects. Trial Name: NCT04097028 — Phase 2

Oxaliplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04097028 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial include those aged fifty or older?

"In accordance with the established parameters, potential participants of this clinical trial must be between 18 and 75 years old."

Answered by AI

Does my profile align with the criteria for participation in this trial?

"The given clinical trial seeks 22 individuals aged between 18 and 75 that have pathologic stage iva esophageal adenocarcinoma ajcc v8. In addition, to be eligible they must satisfy additional conditions: histologically confirmed loco-regional esophageal/gastroesophageal junction adenocarcinoma; surgically resectable disease; haemoglobin >= 9 g/dL; absolute neutrophil count>= 1500mm^3; platelet count>= 100000 mm^3; bilirubin < 1.5 x ULN (upper limit"

Answered by AI

Could you elucidate on other research initiatives exploring Trifluridine and Tipiracil Hydrochloride?

"Presently, there are a total of 378 active clinical trials looking into Trifluridine and Tipiracil Hydrochloride with 126 in the advanced Phase 3 stage. Most investigations for this drug combination originate from Woolloongabba, Queensland; however, 14181 locations around the world have Trifluridine and Tipiracil Hydrochloride experimental studies underway."

Answered by AI

Is the enrollment period for this trial still active?

"Data hosted on clinicaltrials.gov reveals that the enrollment for this particular study has been concluded; it was first posted in December 20th 2019, and last edited November 22nd 2022. However, there are still over 1300 other trials actively seeking participants at present."

Answered by AI

How is Trifluridine and Tipiracil Hydrochloride customarily applied?

"Patients previously treated with oxaliplatin chemotherapy, anti-vegf medication, and diagnosed with stage III colon cancer can benefit from Trifluridine and Tipiracil Hydrochloride therapy."

Answered by AI

How extensive is the population participating in this clinical experiment?

"At the present moment, this medical trial is not recruiting. It was first published on December 20th 2019 and recently edited November 22nd 2022. For those seeking alternative studies, 957 clinical trials are currently searching for patients with pathologic stage iva esophageal adenocarcinoma ajcc v8 while 378 trials require participants who meet criteria concerning Trifluridine and Tipiracil Hydrochloride treatments."

Answered by AI

Has the Food and Drug Administration given its stamp of approval to Trifluridine and Tipiracil Hydrochloride?

"Our assessment in Power put trifluridine and tipiracil hydrochloride's safety at a 2 due to the Phase 2 trial status, indicating there is some proof of its security but none affirming its efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Use of Trifluridine/Tipiracil and Oxaliplatin as Induction Chemotherapy for the Treatment of Resectable Esophageal or Gastroesophageal Junction (GEJ) Adenocarcinoma

2019. "Use of Trifluridine/Tipiracil and Oxaliplatin as Induction Chemotherapy for the Treatment of Resectable Esophageal or Gastroesophageal Junction (GEJ) Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04097028.

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