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Brief Title: Chemotherapy Induction and Chemoradiotherapy in Patients With Esophageal Carcinoma
Official Title: Chemotherapy Induction and Chemoradiotherapy Combined With Cetuximab Respectively in Patients With Non-Metastatic Esophageal Carcinoma: A Multicentric Phase II Study
Study ID: NCT00735345
Brief Summary: The aim of this study is the evaluate the feasibility and safety of chemotherapy induction treatment combined with cetuximab followed by chemoradiotherapy combined with cetuximab in the treatment of patients with non-metastatic esophageal cancer.
Detailed Description: 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 preoperative therapy.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Landeskrankenhaus Feldkirch, Feldkirch, , Austria
Universitätsklinikum Graz, Graz, , Austria
Universitätsklinik Innsbruck, Innsbruck, , Austria
A.ö. Landeskrankenhaus Leoben, Leoben, , Austria
Universitaetsklinik f. Innere Medizin III, Salzburg, , Austria
Krankenhaus Barmherzige Brueder St. Veit a.d. Glan, St. Veit/ Glan, , Austria
Klinikum Kreuzschwestern Wels GmbH, Wels, , Austria
Name: Wolfgang Eisterer, Prof. Dr.
Affiliation: Medizinische Universitaet Innsbruck
Role: PRINCIPAL_INVESTIGATOR