Preoperative Chemoradiation With Capecitabine and Cetuximab

Inclusion Criteria: * Age: 18-80 * bioptical confirmed adenocarcinoma of the rectum in operable T3-T4NxM0 status. In spite of infiltration of the neighbouring organs the tumor has to be basically surgically complete resectable * no former chemotherapy, radiotherapy of pelvis or abdomen and/or tumor resection of a rectum carcinoma * WHO performance status 0-2 * adequate bone marrow reserve (granulocytes - not more than 1.500/µl; thrombocytes - not more than 100.000/µl) * adequate hepatic function ( bilirubin - not more than 1.5 x ULN; GOT and GPT - not more than 3.5 x ULN) * adequate renal function (creatinin - not more than 1.5 mg/dl) * women of childbearing potential: exclusion of pregnancy (negative urin or serum pregnancy test) * willingness of women of childbearing potential and accordingly of potent men to use approved contraceptives (e.g. birth-control pill, loop, condom) during and at least 3 month after conclusion of the study * life expectancy of at least 3 month * signed Informed Consent before recruitment * exclusion of distant metastases at the time of recruitment Exclusion Criteria: * former radiotherapy of pelvis or abdomen * former chemotherapy * any other kind of malign tumor (except adequate treated skin basalioma or in situ cervical carcinoma) in the last 5 years * general contraindication or known hypersensitivity against Cetuximab and/or Capecitabine * Non malign disease, if there is a contraindication with radiotherapy or chemotherapy with Cetuximab an…