Preoperative Chemoradiation With Capecitabine and Cetuximab

Austrian Breast & Colorectal Cancer Study Group

Status and phase

Completed

Phase 2

Conditions

Rectal Cancer

Treatments

Drug: Cetuximab

Drug: Capecitabine

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

ABCSG R03 (96) / TAKO 06

Details and patient eligibility

About

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

Enrollment

31 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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