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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Landeskrankenhaus Feldkirch
Feldkirch, Austria
Universitätsklinikum Graz
Graz, Austria
Universitätsklinik Innsbruck
Innsbruck, Austria
A.ö. Landeskrankenhaus Leoben
Leoben, Austria
Response rate
Time frame: Duration of study
Percentage of complete remissions and resection rate
Time frame: Duration of study
Occurrence of toxicities
Time frame: Duration of study
Evaluation of Quality of Life
Time frame: Duration of study
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Cetuximab: 400 mg/m2 i.v. d1; 250mg/m2 weekly d8 through d85
39.6 Gy total dose
Krankenhaus Barmherzige Brueder St. Veit a.d. Glan
Saint Veit/ Glan, Austria
Universitaetsklinik f. Innere Medizin III
Salzburg, Austria
Klinikum Kreuzschwestern Wels GmbH
Wels, Austria