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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

Brief Summary:
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 or disease Intervention/treatment Phase
Rectal Cancer Drug: cetuximab, capecitabine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
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
Study Start Date : February 2007
Actual Primary Completion Date : April 2009
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

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 identifier (NCT number): NCT00689702

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

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Responsible Party: Vaneja Velenik, PhD, MD,, Institute of Oncology Ljubljana, Slovenia Identifier: NCT00689702    
Other Study ID Numbers: EMR 62202-688
First Posted: June 4, 2008    Key Record Dates
Last Update Posted: March 26, 2012
Last Verified: March 2012
Keywords provided by Institute of Oncology Ljubljana:
rectal cancer
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological