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Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma
Sponsor: Mayo Clinic
Summary
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.
Official title: Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal/Gastroesophageal Junction Adenocarcinoma (PHOX)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
99
Start Date
2023-11-20
Completion Date
2031-05-30
Last Updated
2026-02-27
Healthy Volunteers
No
Conditions
Interventions
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT and PET/CT scan
Endoscopic Ultrasound
Undergo EUS
Esophagogastroduodenoscopy
Undergo EGD
Fluorouracil
Given IV
Hypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy
Leucovorin Calcium
Given IV
Oxaliplatin
Given IV
Positron Emission Tomography
Undergo PET and PET/CT scan
Survey Administration
Ancillary studies
Docetaxel
Given IV
Durvalumab
Given IV
Locations (3)
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States