Preoperative Chemoradiation With Capecitabine and Cetuximab

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

• 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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Austrian Breast & Colorectal Cancer Study Group
• Collaborators: Hoffmann-La Roche; Merck Gesellschaft mbH, Austria
• Treatments: Capecitabine; Cetuximab

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-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