Preoperative chemoradiation with capecitabine and cetuximab within a multidisciplinary therapeutic approach in patients with operable T3-T4 rectalcancer: a phase II study
- Conditions
- locally advanced operable rectal carcinoma (cT3-T4NxM0)
- Registration Number
- EUCTR2005-003740-62-AT
- Lead Sponsor
- ABCSG (Austrian Breast & Colorectal Cancer Study Group)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- 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-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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>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
- Secondary Outcome Measures
Name Time Method