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Completed

NCT Number: NCT00297128

Preoperative Chemoradiation With Capecitabine and Cetuximab

* 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

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital BHB St. Veit/Glan, Surgery, Saint Veit A. D. Glan, Carinthia, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capecitabine

Drug

825 mg/m2 bid (on each therapy day of first 4 therapy weeks)

Other names: Xeloda

Cetuximab

Drug

400mg/m2 week 1, 250mg/m2 week 2-4

Other names: Erbitux

Primary outcomes

  1. feasibility and tolerance of preoperative therapy with Cetuximab in combination with Capecitabine and radiotherapy for patients with locally advanced operable rectal carcinoma

    Time frame: descriptive evaluation

Secondary outcomes

  1. collection of response rate (T-downstaging, pCR), correlation of responsiveness with EGFR-status

    Time frame: description evaluation

Sponsors and collaborators

Lead sponsor

Austrian Breast & Colorectal Cancer Study Group

Network

Collaborators

  • Hoffmann-La Roche
  • Merck Gesellschaft mbH, Austria

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Feb 28, 2006
Registry last updated
Dec 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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