Phase II Study of Short-Course Preoperative Radiation with FOLFOX Chemotherapy for Stage I-III Esophageal or Gastroesophageal Junction Adenocarcinoma

What this Trial Is About

Researchers are evaluating a new preoperative treatment combining hypofractionated radiation therapy with chemotherapy drugs fluorouracil, oxaliplatin, and leucovorin calcium FOLFOX for patients with stage I-III esophageal or gastroesophageal junction adenocarcinoma. This phase II trial aims to test whether this shorter, higher-dose radiation approach combined with chemotherapy can kill more tumor cells and reduce side effects. The study also compares outcomes with historical data and explores various effects including survival, toxicity, and quality of life. Participants first receive induction chemotherapy with a combination of 5-FU, leucovorin calcium, oxaliplatin, and docetaxel FLOT, with some also receiving durvalumab. Following this, they undergo a three-week course of daily radiation therapy combined with two cycles of FOLFOX chemotherapy. The study involves several procedures including esophagogastroduodenoscopy EGD, endoscopic ultrasound EUS, CT and PET scans, and blood and tissue sample collection for research. Throughout the study, participants are closely monitored with follow-up visits at 6, 12, and 24 months, and then up to 5 years. Researchers assess tumor response, side effects, quality of life, financial impact, survival, and long-term toxicity. The study also evaluates differences in toxicity between proton and photon radiation therapies and investigates biomarkers to predict treatment response and personalize future therapies.

Preoperative Hypofractionated Radiotherapy With FOLFOX for Esophageal or Gastroesophageal Junction Adenocarcinoma