Cetuximab (Erbitux®), Capecitabine and Radiotherapy in Neoadjuvant Treatment of Patients With Locally Advanced Resectable Rectal Cancer: A Phase II Pilot Study
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete pathological remission rate
at pathological examm of surgical speciment
No
Vaneja Velenik, PhD, MD
Principal Investigator
Institute of Oncology, Ljubljana, Slovenia
Slovenia: Agency for Medicinal Products - Ministry of Health
EMR 62202-688
NCT00689702
February 2007
May 2013
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