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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Institute of Oncology Ljubljana.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00689702
First Posted: June 4, 2008
Last Update Posted: March 26, 2012
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.
Information provided by:
Institute of Oncology Ljubljana
  Purpose
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.

Condition Intervention Phase
Rectal Cancer Drug: cetuximab, capecitabine Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cetuximab (Erbitux®), Capecitabine and Radiotherapy in Neoadjuvant Treatment of Patients With Locally Advanced Resectable Rectal Cancer: A Phase II Pilot Study

Resource links provided by NLM:


Further study details as provided by Institute of Oncology Ljubljana:

Primary Outcome Measures:
  • Complete pathological remission rate [ Time Frame: at pathological examm of surgical speciment ]

Secondary Outcome Measures:
  • Rate of sphincter sparing surgical procedure Toxicity/safety [ Time Frame: Toxicity/safety:during preoperative treatment, early and late postoperative follow up ]

Enrollment: 43
Study Start Date: February 2007
Estimated Study Completion Date: May 2013
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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
Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00689702


Locations
Slovenia
Institute of Oncology
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
Institute of Oncology Ljubljana
Investigators
Principal Investigator: Vaneja Velenik, PhD, MD Institute of Oncology, Ljubljana, Slovenia
  More Information

Publications:
Responsible Party: Vaneja Velenik, PhD, MD,, Institute of Oncology Ljubljana, Slovenia
ClinicalTrials.gov Identifier: NCT00689702     History of Changes
Other Study ID Numbers: EMR 62202-688
First Submitted: May 30, 2008
First Posted: June 4, 2008
Last Update Posted: March 26, 2012
Last Verified: March 2012

Keywords provided by Institute of Oncology Ljubljana:
cetuximab
capecitabine
radiotherapy
rectal cancer

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Cetuximab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents