Preoperative Chemoradiation With Capecitabine and Cetuximab
- Registration Number
- NCT00297128
- Lead Sponsor
- Austrian Breast & Colorectal Cancer Study Group
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Capecitabine - 1 Cetuximab -
- Primary Outcome Measures
Name Time Method feasibility and tolerance of preoperative therapy with Cetuximab in combination with Capecitabine and radiotherapy for patients with locally advanced operable rectal carcinoma descriptive evaluation
- Secondary Outcome Measures
Name Time Method collection of response rate (T-downstaging, pCR), correlation of responsiveness with EGFR-status description evaluation
Trial Locations
- Locations (10)
Medical University of Graz, Oncology
🇦🇹Graz, Styria, Austria
Hospital Wiener Neustadt, Surgery
🇦🇹Wiener Neustadt, Lower Austria, Austria
Hospital BHB St. Veit/Glan, Surgery
🇦🇹St. Veit a. d. Glan, Carinthia, Austria
Hospital BHS Linz, Radiooncology
🇦🇹Linz, Upper Austria, Austria
Paracelsus Medical University Salzburg - Oncology
🇦🇹Salzburg, Austria
Medical University of Innsbruck, Surgery
🇦🇹Innsbruck, Tyrol, Austria
State Hospital Leoben
🇦🇹Leoben, Styria, Austria
Klinikum Wels-Grieskirchen
🇦🇹Wels, Upper Austria, Austria
State Hospital Feldkirch
🇦🇹Feldkirch, Vorarlberg, Austria
Medical University of Vienna, Radiotherapy
🇦🇹Vienna, Austria