Preoperative Chemoradiation With Capecitabine and Cetuximab Within a Multidisciplinary Therapeutic Approach in Patients With Operable T3-T4 Rectal Cancer: a Phase II Study
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