Rectal Cancer
Conditions
Keywords
pilot study, rectal, cancer, phase II, preoperative, chemoradiation, capecitabine, cetuximab, operable, T4, ABCSG, TAKO, R03, 96, 06
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
Interventions
DRUGCapecitabine
825 mg/m2 bid (on each therapy day of first 4 therapy weeks)
DRUGCetuximab
400mg/m2 week 1, 250mg/m2 week 2-4
Sponsors
Hoffmann-La Roche
Merck Gesellschaft mbH, Austria
Austrian Breast & Colorectal Cancer Study Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| collection of response rate (T-downstaging, pCR), correlation of responsiveness with EGFR-status | description evaluation |
Countries
Austria
Outcome results
None listed