Cetuximab (Erbitux®), Capecitabine and Radiotherapy in Neoadjuvant Treatment of Patients With Rectal Cancer (XERT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00689702
Recruitment Status : Unknown
Verified March 2012 by Institute of Oncology Ljubljana.
Recruitment status was:  Active, not recruiting
First Posted : June 4, 2008
Last Update Posted : March 26, 2012
Information provided by:
Institute of Oncology Ljubljana

May 30, 2008
June 4, 2008
March 26, 2012
February 2007
April 2009   (Final data collection date for primary outcome measure)
Complete pathological remission rate [ Time Frame: at pathological examm of surgical speciment ]
Same as current
Complete list of historical versions of study NCT00689702 on Archive Site
Rate of sphincter sparing surgical procedure Toxicity/safety [ Time Frame: Toxicity/safety:during preoperative treatment, early and late postoperative follow up ]
Same as current
Not Provided
Not Provided
Cetuximab (Erbitux®), Capecitabine and Radiotherapy in Neoadjuvant Treatment of Patients With Rectal Cancer
Cetuximab (Erbitux®), Capecitabine and Radiotherapy in Neoadjuvant Treatment of Patients With Locally Advanced Resectable Rectal Cancer: A Phase II Pilot Study
This is a nonrandomised pilot trial to establish the role of intravenous cetuximab when added to a schedule of capecitabine plus pelvic radiation in patients who have locally advanced primary resectable rectal cancers.
Preoperative radiotherapy and 5-FU based chemotherapy, along with the complete resection of the mesorectum is a standard treatment of locally advanced rectal cancer.Capecitabine has the potential to replace 5-FU as standard agent. Cetuximab is a monoclonal antibody directed against EGFR. Both agents are active in treatment of colorectal cancer and have demonstrated radiosensitising properties.The trial aims to assess the efficacy, safety and toxicity of the combination of cetuximab, capecitabine and radiation in patients with stage II and III rectal cancer.
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Rectal Cancer
Drug: cetuximab, capecitabine

Cetuximab 400mg/m2 in iv infusion as an initial dose on day 15, then a weekly dose of 250mg/m2 for 5 weeks during radiotherapy (days 22, 29, 36, 43, 50).

Capecitabine: 1250 mg/m² bd for 14 days (1 cycle); 825mg/m2 bd over 5 weeks during radiotherapy.

Radiotherapy: planned total dose of 45 Gy in 25 fractions using a four-field plan in 5 weeks.

Other Names:
  • Erbitux
  • Xeloda
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
May 2013
April 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18 to 80 if judged fit for surgery
  • WHO performance status 0-1
  • Histologically proven rectal adenocarcinoma located below the peritoneum
  • T3-T4 or/and nodal involvement determined by rectal ultrasound or computed tomography (CT) or MRI
  • No distant metastases
  • Adequate haematological, cardiac, liver and renal function
  • Signed informed consent
  • Appropriate measures for contraception for men and women, if applicable

Exclusion Criteria:

  • Prior radio- and/or chemotherapy
  • Others synchronous cancers
  • History of other malignant disease
  • Significant heart disease
  • Known hypersensitivity to biological drugs
  • Pregnant or lactating patient
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
EMR 62202-688
Not Provided
Not Provided
Vaneja Velenik, PhD, MD,, Institute of Oncology Ljubljana, Slovenia
Institute of Oncology Ljubljana
Not Provided
Principal Investigator: Vaneja Velenik, PhD, MD Institute of Oncology, Ljubljana, Slovenia
Institute of Oncology Ljubljana
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP