P1.131. Total Neoadjuvant Therapy for Lymph Node-Positive Adenocarcinoma of the OESophagus and Oesophagogastric Junction, Phase-II Multicentre Randomized Controlled Trial Protocol

Topic Esophageal Cancer: Oncology/Radiation Therapy Background Neoadjuvant chemoradiotherapy (nCRT) and perioperative chemotherapy both form standard treatment for locally advanced oesophageal adenocarcinoma. By combining both therapies as Total Neoadjuvant Therapy (TNT), the local effect of nCRT and the systemic effect of chemotherapy could potentially lead to better disease control. Methods The TNT-OES-2 trial is a phase-II multicentre randomized controlled trial which combines neoadjuvant chemoradiotherapy (CROSS: 41.4 Gy + carboplatin/paclitaxel) and neoadjuvant chemotherapy (FLOT: 5-FU, Leucovorin, Oxaliplatin, Docetaxel, 4 cycles) in patients with lymph-node positive adenocarcinoma of the oesophagus or oesophagogastric junction. In total, 216 patients will be randomized in a 1:1 ratio to either arm A: TNT FLOT-CROSS or arm B: TNT CROSS-FLOT, in 11 specialised centers in the Netherlands. The primary endpoint is progression free survival at two years after randomization. Secondary objectives are feasibility, overall survival, toxicity, postoperative morbidity and mortality and quality of life. Conclusion The TNT-OES-2 trial compares TNT FLOT-CROSS with TNT CROSS-FLOT. If TNT shows promising results, the superior sequence will be examined in a consecutive phase III trial.