Definitive Radiochemotherapy Plus/Minus Cetuximab in Unresectable Locally Advanced Esophageal Cancer
Status:
Completed
Trial end date:
2018-09-06
Target enrollment:
Participant gender:
Summary
Esophageal cancer is a highly aggressive tumor. Treatment options are various and range from
chemotherapy to radiotherapy and several surgical techniques. Nevertheless, the overall
survival rates for this disease remain poor.
During the last years the combination of cetuximab with standard chemotherapy or radiotherapy
has mainly be investigated in clinical trials focusing on colorectal and/or head and neck
cancer.
The results obtained from theses studies were very encouraging and led to the initiation of
active clinical research in esophageal cancer patients with antibody inhibition of the
epidermal growth factor receptor (EGFR).
The first data in this indication are encouraging showing that cetuximab can safely be added
to chemoradiation for esophageal cancer patients with first hints of efficacy.
Based on the experiences with cetuximab in colorectal cancer and in combination with
radiotherapy in head and neck cancer, the aim of the present study is to evaluate the
feasibility of a combined treatment of cetuximab with continuous infusional 5-FU, cisplatin
and radiotherapy in patients with esophageal cancer and to assess if the overall survival
rates can be increased by addition of an EGFR-targeted therapy.
Phase:
Phase 2
Details
Lead Sponsor:
University Hospital Schleswig-Holstein University of Schleswig-Holstein