Radiochemotherapy with or without cetuximab for unresectable esophageal cancer: final results of a randomized phase 2 trial (LEOPARD-2).

ABSTRACT:

Purpose

To investigate the efficacy and toxicity of cetuximab when added to radiochemotherapy for unresectable esophageal cancer.

Methods

This randomized phase 2 trial (clinicaltrials.gov, identifier NCT01787006) compared radiochemotherapy plus cetuximab (arm A) to radiochemotherapy (arm B) for unresectable esophageal cancer. Primary objective was 2‑year overall survival (OS). Arm A was considered insufficiently active if 2‑year OS was ≤40% (null hypothesis = H₀), and promising if the lower limit of the 95% confidence interval was >45%. If that lower limit was >40%, H₀ was rejected. Secondary objectives included progression-free survival (PFS), locoregional control (LC), metastases-free survival (MFS), response, and toxicity. The study was terminated ea

SUBMITTER: Rades D 

PROVIDER: S-EPMC7449950 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature