Clinical trial NCT00297128: Preoperative Chemoradiation With Capecitabine and Cetuximab
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rectal Cancer
Keywords: pilot study
rectal
cancer
phase II
preoperative
chemoradiation
capecitabine
cetuximab
operable
T4
ABCSG
TAKO
R03
96
06
Lead sponsor: Austrian Breast & Colorectal Cancer Study Group
Sponsor class: NETWORK
Collaborators: name: Hoffmann-La Roche
name: Merck Gesellschaft mbH, Austria
First posted: 2006-02-28
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: feasibility and tolerance of preoperative therapy with Cetuximab in combination with Capecitabine and radiotherapy for patients with locally advanced operable rectal carcinoma
timeFrame: descriptive evaluation
Secondary outcomes:
measure: collection of response rate (T-downstaging, pCR), correlation of responsiveness with EGFR-status
timeFrame: description evaluation
Other outcomes:
Locations:
city: St. Veit a. d. Glan
country: Austria
facility: Hospital BHB St. Veit/Glan, Surgery
state: Carinthia
city: Wiener Neustadt
country: Austria
facility: Hospital Wiener Neustadt, Surgery
state: Lower Austria
city: Graz
country: Austria
facility: Medical University of Graz, Oncology
state: Styria
city: Leoben
country: Austria
facility: State Hospital Leoben
state: Styria
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck, Surgery
state: Tyrol
city: Linz
country: Austria
facility: Hospital BHS Linz, Radiooncology
state: Upper Austria
city: Wels
country: Austria
facility: Klinikum Wels-Grieskirchen
state: Upper Austria
city: Feldkirch
country: Austria
facility: State Hospital Feldkirch
state: Vorarlberg
city: Salzburg
country: Austria
facility: Paracelsus Medical University Salzburg - Oncology
city: Vienna
country: Austria
facility: Medical University of Vienna, Radiotherapy
Study officials:
affiliation: Austrian Breast & Colorectal Cancer Study Group
name: Josef Thaler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Austrian Breast & Colorectal Cancer Study Group
name: Joerg Tschmelitsch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Austrian Breast & Colorectal Cancer Study Group
name: Alexander de Vries, MD
role: PRINCIPAL_INVESTIGATOR
References: