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

Phase 2

• Conditions: Rectal Cancer

• Registration Number: NCT00689702
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2008-05-30
• Study First Submitted QC: 2008-05-30
• Study First Posted: 2008-06-04
• Primary Completion: 2009-04
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-23
• Last Update Posted: 2012-03-26
• Study Completion: 2013-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Complete pathological remission rate	at pathological examm of surgical speciment

Secondary Outcome Measures

Name	Time	Method
Rate of sphincter sparing surgical procedure Toxicity/safety	Toxicity/safety:during preoperative treatment, early and late postoperative follow up

Trial Locations

Locations (1)

Institute of Oncology; 🇸🇮 Ljubljana, Slovenia