Preoperative Chemoradiation With Capecitabine and Cetuximab

• feasibility and tolerance of preoperative therapy with Cetuximab in combination with Capecitabine and radiotherapy for patients with locally advanced operable rectal carcinoma
• collection of response rate (T-downstaging, pathological complete remission), correlation of responsiveness with EGFR-status

• Drug: Capecitabine
  825 mg/m2 bid (on each therapy day of first 4 therapy weeks)
  Other Name: Xeloda
• Drug: Cetuximab
  400mg/m2 week 1, 250mg/m2 week 2-4
  Other Name: Erbitux

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

• Hoffmann-La Roche
• Merck Gesellschaft mbH, Austria