Safety and Efficacy Study of Icotinib With Intensity-modulated Radiotherapy in Nasopharyngeal Carcinoma
Status:
Completed
Trial end date:
2015-02-01
Target enrollment:
Participant gender:
Summary
Nasopharyngeal carcinoma (NPC) is a prevalent disease in southeast of China. Radiation
therapy with or without chemotherapy is a standard therapy for nasopharyngeal cancer.
Cytotoxic chemotherapy plays an important role in the curative treatment of advanced NPC.
However, concurrent chemoradiotherapy increased significantly local and systemic toxic
effects, which may preclude many patients from proceeding with combined therapy. The
epidermal growth factor receptor(EGFR) gene is amplified in 40% and EGFR protein is
overexpressed in over 80% of NPC. EGFR overexpression is also associated with shorter
survival following chemoradiotherapy in locoregionally advanced NPC. And some basic
researches have proved that EGFR tyrosine kinase inhibitors(TKIs) could increase the
radiosensitivity and reduce the epithelial-mesenchymal transition (EMT) in NPC cell line.
Moreover, distant metastases has been the major cause of treatment failure in NPC. Icotinib
hydrochloride is a novel oral EGFR TKIs with low mammalian toxicity(made in China). But base
on toxic effects of Icotinib, it may increase toxic effects about skin and mucosa in
combination therapy with Icotinib and Intensity-modulated Radiotherapy (IMRT). The
prospective study will assess the tolerability and efficacy of Icotinib combined with IMRT in
patients with NPC. This regimen is of great interest and it has potential to alleviate the
adverse effects, improve patient compliance and better therapeutic ratio.