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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Given PO
Given IV
Roswell Park Cancer Institute
Buffalo, New York, United States
Stephenson Oklahoma Cancer Center at the University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States
Number of Patients With a Pathologic Complete Response
Will be determined by pathologic examination of resected specimen: complete response to induction chemotherapy followed by standard chemoradiation and surgery. Will be summarized using frequencies and relative frequencies. Will be estimated using an 80% confidence interval obtained using Jeffrey's prior method. Response is assessed by the tumor regression score (as proposed by NCCN guidelines): Complete Response: No viable cancer cells, including lymph nodes Near Complete Response: Single cells or rare small groups of cancer cells Partial Response: Residual cancer with evident tumor regression but more than single cells or rare small groups of cancer cells Poor or No Response: Extensive residual disease with no evident tumor regression
Time frame: Assessed at the time of surgery (approximately 6 months after start of neoadjuvant therapy)
Median Progression Free Survival
Will be summarized using standard Kaplan-Meier methods; where estimates of median survival and two-year survival rates will be obtained with 95% confidence intervals. Progression is assessed by RECIST v1.0, defined as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: Time from treatment until disease progression, death from disease, or last follow-up, assessed up to 2 years
Median Overall Survival
Will be summarized using standard Kaplan-Meier methods; where estimates of median survival and two-year survival rates will be obtained with 95% confidence intervals
Time frame: Time from treatment until death due to any cause or last follow-up, assessed up to 2 years
Number of Patients With Grade 3 or Higher Treatment Related Adverse Events
Toxicities and adverse events (as per Common Terminology Criteria for Adverse Events version 5.0) will be summarized by attribution and grade using frequencies and relative frequencies.
Time frame: Up to 30 days after last dose of study drug, which is a maximum of 210 days.
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