Association of Radiochemotherapy and Immunotherapy for the Treatment of Unresectable Oesophageal caNcer

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2018
ARION study will randomize 120 patients, in 12 centers in France, according to a ratio 1:1 in the following arm of treatment: ‐ Standard and experimental arm: Definitive modulated‐intensity radiotherapy will be delivered according to boost integrated technique 5 days a week for 5 weeks at a dose of: ‐ 50 Gy delivered in 25 fractions to the macroscopic disease (endoscopic, TDM and fused FDG PET) ‐ 45 Gy to the adjacent peri tumoral mucosis and prophylactic lymph node FOLFOX 4 simplified protocol, 1 infusion every 2 weeks (q2w) during 3 months starting with radiotherapy (+/‐ 1 day): ‐ IV oxaliplatin 85 mg/m² in 2 h on day 1 (D1) ‐ IV Leucovorin 200 mg/m² in 2 h on D1, followed by ‐ IV 5‐FU 400 mg/m² in 10 minutes on D1 followed by ‐ IV continuous infusion 5‐FU 2400 mg/m² in 46 h ‐ Experimental arm: Concomitant administration of durvalumab: Every 4 weeks during concurrent FOLFOX (dose: 1500 mg) and after FOLFOX completion (total of 12 months of treatment).
Epistemonikos ID: 9e33b27e647fce78285ae29ca4d9294668e03088
First added on: May 21, 2024