Use of Trifluridine/Tipiracil and Oxaliplatin as Induction Chemotherapy for the Treatment of Resectable Esophageal or Gastroesophageal Junction (GEJ) Adenocarcinoma
Condition: Clinical Stage IIA Esophageal Adenocarcinoma AJCC v8; Clinical Stage IIA Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage III Esophageal Adenocarcinoma AJCC v8; Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8; Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage IIB Esophageal Adenocarcinoma AJCC v8; Pathologic Stage IIB Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage III Esophageal Adenocarcinoma AJCC v8; Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8; Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8; Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8; Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
MeSH terms: Adenocarcinoma; Esophageal Neoplasms
Intervention: Trifluridine and Tipiracil Hydrochloride; Oxaliplatin
Intervention description: Given PO; Given IV
Intervention MeSH terms: Trifluridine; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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