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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cetuximab (Erbitux®), Capecitabine and Radiotherapy in Neoadjuvant Treatment of Patients With Locally Advanced Resectable Rectal Cancer: A Phase II Pilot Study

Conditions
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Rectal Cancer

Intervention / Treatment
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* Drug: cetuximab, capecitabine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete pathological remission rate |  | at pathological examm of surgical speciment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of sphincter sparing surgical procedure Toxicity/safety |  | Toxicity/safety:during preoperative treatment, early and late postoperative follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cetuximab, capecitabine, radiotherapy, rectal cancer