Status:
COMPLETED
Use of Trifluridine/Tipiracil and Oxaliplatin as Induction Chemotherapy for the Treatment of Resectable Esophageal or Gastroesophageal Junction (GEJ) Adenocarcinoma
Lead Sponsor:
Roswell Park Cancer Institute
Collaborating Sponsors:
National Comprehensive Cancer Network
Conditions:
Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8
Clinical Stage IIA Gastroesophageal Junction Adenocarcinoma AJCC v8
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 adenocarci...
Detailed Description
PRIMARY OBJECTIVE: -Evaluate the pathologic complete response (path CR) rate in participants with esophageal and gastroesophageal junction (GEJ) adenocarcinoma when trifluridine and tipiracil hydroch...
Eligibility Criteria
Inclusion
- Must have histologically proven loco-regional esophageal or gastroesophageal junction adenocarcinoma
- Endoscopic ultrasound (EUS), or clinically determined node-positive disease with any T-stage or T3-T4a with any N stage: Patients with EUS T4b and any M1 cancer will not be included
- Must have potentially resectable disease
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Hemoglobin \>= 9 g/dL
- Absolute neutrophil count \>= 1500/mm\^3
- Platelet count \>= 100,000/mm\^3
- Creatinine \< 1.5 upper limit of normal (ULN)
- Bilirubin \< 1.5 x ULN
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 x ULN
- Capacity to take oral tablet(s) without difficulty
- Participants of child-bearing potential must agree to use highly effective contraceptive methods (e.g., hormonal plus barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion
- Prior chemotherapy, thoracic radiotherapy or prior surgical resection for an esophageal tumor
- Participants with known metastatic disease
- Any concurrent active malignancy that requires active systemic intervention
- Grade 2 or higher peripheral neuropathy
- Participants who have had major surgery or field radiation within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Received an investigational agent within 4 weeks prior to enrollment
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Grade 3 or higher hypersensitivity reaction to oxaliplatin or grade 1-2 hypersensitivity reaction to oxaliplatin not controlled with premedication
- Patient previously treated by TAS 102 or history of allergic reactions attributed to compounds of similar composition to TAS 102 or any of its excipients
- Hereditary problems of galactose intolerance; e.g., Lapp lactase deficiency or glucose galactose malabsorption
- Pregnant or nursing female participants
- Unwilling or unable to follow protocol requirements
- Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
Key Trial Info
Start Date :
December 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2025
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04097028
Start Date
December 20 2019
End Date
February 5 2025
Last Update
April 29 2025
Active Locations (2)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14203
2
Stephenson Oklahoma Cancer Center at the University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States, 73104