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Association of Radiochemotherapy and Immunotherapy for the Treatment of Unresectable Oesophageal caNcer: a Comparative Randomized Phase II Trial
This study aims to assess the efficacy of durvalumab in combination with radiochemotherapy (FOLFOX and IMRT) and then as maintenance therapy for treating patients with localised unresectable oesophageal cancer. This is a randomized, French national, multicentre, comparative phase II trial
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).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Centre Oscar Lambret, CLCC UNICANCER
Lille, France
Hôpital Saint Louis, APHP
Paris, France
Hôpital Haut-Lévêque
Pessac, France
Centre Hospitalier Universitaire
Poitiers, France
Centre Paul Strauss, CLCC UNICANCER
Strasbourg, France
Iuct, Clcc Unicancer
Toulouse, France
CHU Rangueil Larrey
Toulouse, France
Start Date
December 5, 2018
Primary Completion Date
May 24, 2024
Completion Date
December 1, 2024
Last Updated
November 18, 2025
112
ACTUAL participants
Durvalumab
DRUG
IMRT 50 Gy + FOLFOX4 simplifIed (oxaliplatin, leucovorin, 5-FU)
COMBINATION_PRODUCT
Lead Sponsor
UNICANCER
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT02735057