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

Sponsor
UNICANCER
Study ID
NCT03777813
Phase
PHASE2
Status
Completed

Conditions

  • Esophagus Cancer
  • Unresectable Malignant Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Radiochemotherapy in standard arm and in experimental arm: 10 weeks (RT 50 Gy and FOLFOX q2w) Immunotherapy in experimental arm only: Patients will received concomitantly a maximum of 12 infusions
  • IMRT 50 Gy + FOLFOX4 simplifIed (oxaliplatin, leucovorin, 5-FU) — COMBINATION_PRODUCT
    Radiochemotherapy in standard arm and in experimental arm: 10 weeks (RT 50 Gy and FOLFOX q2w)

Study Details

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

Key Dates

Start date
Dec 5, 2018
Status verified
Sep 2024
Primary completion
May 24, 2024
Completion
Dec 1, 2024

Study Design

Enrollment
112 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Concomitant administration of durvalumab (dose: 1500 mg): Every 4 weeks during concurrent FOLFOX and after FOLFOX completion (total of 12 months of treatment) 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 during 3 months starting with radiotherapy (+/- 1 day): * IV oxaliplatin 85 mg/m² in 2 h on 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
  • Active Comparator: Arm B
    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 during 3 months starting with radiotherapy (+/- 1 day): * IV oxaliplatin 85 mg/m² in 2 h on 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

Primary Outcome Measure

cPFS (centrally reviewed cPFS) [ Time Frame: 12-months cPFS ]

Related Studies