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Brief Title: Safety and Efficacy Study of Icotinib With Intensity-modulated Radiotherapy in Nasopharyngeal Carcinoma
Official Title: Phase Ⅰ/Ⅱ Study of Icotinib Hydrochloride Combined With Intensity-modulated Radiotherapy in Nasopharyngeal Cancer
Study ID: NCT01534585
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Taizhou Hospital, Wenzhou Medical College, Taizhou, Zhejiang, China
Name: Haihua Yang, MD.
Affiliation: Department of Radiation Oncology, Taizhou Hospital, Wenzhou Medical College.
Role: STUDY_DIRECTOR
Name: Wei Hu, MD.
Affiliation: Department of Radiation Oncology, Taizhou Hospital, Wenzhou Medical College.
Role: STUDY_CHAIR
Name: Wei Wang, BS
Affiliation: Department of Radiation Oncology, Taizhou Hospital, Wenzhou Medical College.
Role: PRINCIPAL_INVESTIGATOR
Name: Chao Zhou, MD.
Affiliation: Department of Radiation Oncology, Taizhou Hospital, Wenzhou Medical College.
Role: PRINCIPAL_INVESTIGATOR