locally advanced operable rectal carcinoma (cT3-T4NxM0)
Conditions
Sponsors
ABCSG (Austrian Breast & Colorectal Cancer Study Group)
Eligibility
Sex/Gender
All
Inclusion criteria
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-controll 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - former radiotherapy of pelvis or abdomen - former chemotherapy - any other kind of malign tumor in the last 5 years (except adequate treated skin basalioma or in situ cervical carcinoma) - general contraindiction or known hypersensitivity against Cetuximab and/or Capecitabine - Non malign disease, if there is a contraindication with radiotherapy or chemotherapy with Cetuximab and Capecitbine 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: feasibility and tolerance of preoperative therapy with Cetuximab in combination with Capecitabine and radiotherapy for patients with locally advanced operable rectal carcinoma;Secondary Objective: collection of response rate (T-downstaging, pathological complete remission), correlation of responsiveness with EGFR-status correlation of response with Anti-EGFR-antibody-therapy with K-RAS mutationstatus;Primary end point(s): feasibility and tolerance of preoperative therapy with Cetuximab in combination with Capecitabine and radiotherapy for patients with locally advanced operable rectal carcinoma | — |
Countries
Austria
Outcome results
None listed