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 and Capecitabine or a resection of the rectum: high-graded cardiac insufficiency, angina pectoris, hypertension or arrhythmia, hepatic disease, significant neurological or psychiatric disorders florid, serious infections at the time of recruitment legally limited contractual capability or evidence of neurological or psychiatric disease, if it will constrict the patients compliance in the opinion of the investigator evidence of lacking cooperation of the patient pregnant or breast feeding women