drugset / Trial / NCT06078709

Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma

NCT06078709 ↗

Phase 2 Recruiting 99 enrolled Mayo Clinic
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2023-11-20
Primary completion
2027-05-30
Completion
2027-05-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule — Intravenous
Subject Durvalumab Monoclonal antibody — Intravenous
Subject Oxaliplatin Small molecule — Intravenous
Subject fluorouracil Small molecule — Intravenous
Background Leucovorin Small molecule — Intravenous