Chemotherapy Induction and Chemoradiotherapy Combined With Cetuximab Respectively in Patients With Non-Metastatic Esophageal Carcinoma: A Multicentric Phase II Study
Patients with a locoregional carcinoma of the esophagus or gastro-esophageal junction have a
low survival prognosis following surgical resection. In studies published to date no
positive effect upon overall survival could be demonstrated for preoperative chemotherapy or
chemoradiotherapy. However, patients with a complete remission following preoperative
therapy show prolonged survival.
This study design is based upon decreasing primary tumour and preventing oder delaying
micrometastases by means of a chemo induction therapy, increasing R0 resection rates and
preventing local recurrence by means of preoperative chemoradiotherapy, increasing the
radiosensitivity of tumour cells through treatment combination with cetuximab, surgical
resection of the locoregional primary tumour or definitive radiochemotherapy in case the
primary tumour is inoperable.
The aim of this study is therefore to evaluate the feasibility and safety of a 3-staged
therapy approach including an EGFR antibody in the treatment of patients with potentially
resectable esophageal cancer, as well as the evaluation of objective response rates to this
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Duration of study
Wolfgang Eisterer, Prof. Dr.
Medizinische Universitaet Innsbruck