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Spots Global Cancer Trial Database for Association of Radiochemotherapy and Immunotherapy for the Treatment of Unresectable Oesophageal caNcer

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Trial Identification

Brief Title: Association of Radiochemotherapy and Immunotherapy for the Treatment of Unresectable Oesophageal caNcer

Official Title: Association of Radiochemotherapy and Immunotherapy for the Treatment of Unresectable Oesophageal caNcer: a Comparative Randomized Phase II Trial

Study ID: NCT03777813

Study Description

Brief Summary: 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

Detailed Description: 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).

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Anouchka Modesto, Doctor

Affiliation: Institut Claudius Regaud

Role: PRINCIPAL_INVESTIGATOR

Name: Laurent Quero, Doctor

Affiliation: Hôpital Saint Louis / Université Paris Diderot

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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