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

NCT03777813 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2025-11-18

No results posted yet for this study

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

Conditions

  • Esophagus Cancer
  • Unresectable Malignant Neoplasm

Interventions

DRUG

Durvalumab

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

COMBINATION_PRODUCT

IMRT 50 Gy + FOLFOX4 simplifIed (oxaliplatin, leucovorin, 5-FU)

Radiochemotherapy in standard arm and in experimental arm: 10 weeks (RT 50 Gy and FOLFOX q2w)

Sponsors & Collaborators

  • UNICANCER

    lead OTHER

Principal Investigators

  • Anouchka Modesto, Doctor · Institut Claudius Regaud

  • Laurent Quero, Doctor · Hôpital Saint Louis / Université Paris Diderot

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-05
Primary Completion
2024-05-24
Completion
2024-12-01

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03777813 on ClinicalTrials.gov