Esophageal Cancer Clinical Trial
Use of Trifluridine/Tipiracil and Oxaliplatin as Induction Chemotherapy for the Treatment of Resectable Esophageal or Gastroesophageal Junction (GEJ) Adenocarcinoma
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 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.
Full Description
PRIMARY OBJECTIVE:
-Evaluate the pathologic complete response (path CR) rate in participants with esophageal and gastroesophageal junction (GEJ) adenocarcinoma when trifluridine and tipiracil hydrochloride (trifluridine/tipiracil [TAS-102]) and oxaliplatin are used as induction chemotherapy prior to surgical resection.
SECONDARY OBJECTIVES:
Evaluate the 2-year disease-free survival (DFS) and the 2-year overall survival (OS)
To determinate the safety and tolerability of induction chemotherapy with trifluridine/tipiracil (TAS 102) and oxaliplatin followed by standard chemoradiation and surgery
Evaluate the metabolic response to induction chemotherapy with TAS 102 and oxaliplatin in participants with esophageal and gastroesophageal junction (GEJ) adenocarcinoma prior to standard chemoradiation and surgical resection
EXPLORATORY OBJECTIVE:
-Correlate circulating tumor deoxyribonucleic acid (DNA) levels with disease recurrence and metabolic response on positron emission tomography (PET) computed tomography (CT).
OUTLINE:
Patients receive oxaliplatin intravenously (IV) over 2 hours on day 1 and trifluridine and tipiracil hydrochloride orally (PO) twice daily (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.
After completion of study treatment, patients are followed up every 3-6 months for years 1-2, every 6-12 months for years 3-5, and then annually thereafter.
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
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There are 2 Locations for this study
Buffalo New York, 14203, United States
Oklahoma City Oklahoma, 73104, United States
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