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

• Status: Unknown status
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Oncology Ljubljana
• Treatments: Capecitabine; Cetuximab

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