Preoperative Chemoradiation With Capecitabine and Cetuximab

Study Overview
=================
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

Official Title
-----------------
Preoperative Chemoradiation With Capecitabine and Cetuximab Within a Multidisciplinary Therapeutic Approach in Patients With Operable T3-T4 Rectal Cancer: a Phase II Study

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Drug: Capecitabine
* Drug: Cetuximab


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Capecitabine<br>* 825 mg/m2 bid (on each therapy day of first 4 therapy weeks)<br>* Other names: Xeloda;Drug: Cetuximab<br>* 400mg/m2 week 1, 250mg/m2 week 2-4<br>* Other names: Erbitux;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| collection of response rate (T-downstaging, pCR), correlation of responsiveness with EGFR-status |  | description evaluation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pilot study, rectal, cancer, phase II, preoperative, chemoradiation, capecitabine, cetuximab, operable, T4, ABCSG, TAKO, R03, 96, 06