Preoperative Chemoradiation With Capecitabine and Cetuximab

Rectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00297128
• Other study ID #: ABCSG R03 (96) / TAKO 06
• Status: Completed
• Phase: Phase 2
• First received: February 27, 2006
• Last updated: December 29, 2011
• Start date: October 2005
• Est. completion date: November 2011

Study information

• Verified date: December 2011
• Source: Austrian Breast & Colorectal Cancer Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectal Cancer

Intervention

Drug:
• Capecitabine
825 mg/m2 bid (on each therapy day of first 4 therapy weeks)
• Cetuximab
400mg/m2 week 1, 250mg/m2 week 2-4

Locations

Country	Name	City	State
Austria	State Hospital Feldkirch	Feldkirch	Vorarlberg
Austria	Medical University of Graz, Oncology	Graz	Styria
Austria	Medical University of Innsbruck, Surgery	Innsbruck	Tyrol
Austria	State Hospital Leoben	Leoben	Styria
Austria	Hospital BHS Linz, Radiooncology	Linz	Upper Austria
Austria	Paracelsus Medical University Salzburg - Oncology	Salzburg
Austria	Hospital BHB St. Veit/Glan, Surgery	St. Veit a. d. Glan	Carinthia
Austria	Medical University of Vienna, Radiotherapy	Vienna
Austria	Klinikum Wels-Grieskirchen	Wels	Upper Austria
Austria	Hospital Wiener Neustadt, Surgery	Wiener Neustadt	Lower Austria

Sponsors (3)

Lead Sponsor	Collaborator
Austrian Breast & Colorectal Cancer Study Group	Hoffmann-La Roche, Merck Gesellschaft mbH, Austria

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	feasibility and tolerance of preoperative therapy with Cetuximab in combination with Capecitabine and radiotherapy for patients with locally advanced operable rectal carcinoma		descriptive evaluation	Yes
Secondary	collection of response rate (T-downstaging, pCR), correlation of responsiveness with EGFR-status		description evaluation	No

External Links

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