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

Institute of Oncology Ljubljana43 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rectal Cancer

Interventions

cetuximab, capecitabineDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Institute of Oncology

Ljubljana, Slovenia, Slovenia

Outcomes

Primary Outcomes

Complete pathological remission rate

Time frame: at pathological examm of surgical speciment

Secondary Outcomes

Rate of sphincter sparing surgical procedure Toxicity/safety

Time frame: Toxicity/safety:during preoperative treatment, early and late postoperative follow up

Data from ClinicalTrials.gov

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