Mayo Clinic
This phase II trial tests how well preoperative (prior to surgery) radiation therapy with fluorouracil, oxaliplatin, and leucovorin calcium (FOLFOX) works for the treatment of stage I-III esophageal or gastroesophageal junction adenocarcinoma. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Fluorouracil stops cells from making deoxyribonucleic acid (DNA) and it may kill tumor cells. Leucovorin is not a chemotherapy medication but is given in conjunction with chemotherapy. Leucovorin is used with the chemotherapy medication fluorouracil to enhance the effects of the fluorouracil, in other words, to make the drug work better. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill tumor cells. Giving preoperative hypofractionated radiation with fluorouracil and oxaliplatin may kill more tumor cells in patients with stage I-III esophageal or gastroesophageal junction adenocarcinoma.
PRIMARY OBJECTIVE: I. To demonstrate non-inferiority of pathologic complete response (pCR) with hypofractionated radiotherapy and concurrent FOLFOX compared to historical controls. SECONDARY OBJECTIVES: I. Report targeted acute grade ≥ 3 gastrointestinal (GI) toxicity, per Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. II. Assess post-operative toxicity for patients undergoing esophagectomy, as determined by the Clavien-Dindo Classification. III. Analyze patient-reported quality of life, per Functional Assessment of Cancer Therapy- Esophageal (FACT-E). IV. Determi…
Inclusion Criteria: * Age ≥ 18 years * Histological confirmation of esophageal or gastroesophageal junction adenocarcinoma, American Joint Committee on Cancer (AJCC) 8th edition stage T1-4N0-3M0 * Candidate for trimodality therapy: neoadjuvant chemo (immuno) therapy, chemoradiation, and esophagectomy * Surgical consultation has confirmed that patient is an appropriate candidate for esophagectomy * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 * Negative pregnancy test done ≤ 7 days prior to chemotherapy, for women of childbearing potential only * Ability to provide…
Undergo blood sample collection
Undergo CT and PET/CT scan
Undergo EUS
Undergo EGD
Given IV
Undergo hypofractionated radiation therapy
Given IV
Given IV
Undergo PET and PET/CT scan
Ancillary studies
Given IV
Given IV