74. The rational for optimal combination of radiation therapy and Taxanes in organ preservation treatment of head and neck cancer – project of clinical study

Because Docetaxel has both radiosensitizing properties as well as good anticancer activity by itself in squamous cell carcinomas we are going to attempt concurrent use of Docetaxel and radiochemiotherapy in patients with advanced head and neck cancers (HNC).AimThe objective of this study is to evaluate the response rate, loco-regional control, disease – free survival and overall survival in previously untreated inoperable HNC patients.MethodsThis is a project of an open non-randomized, one centre, phase II, one arm study. Total planned dose of RT for GTV is 68 Gy given in 40 fractions, once daily, 7 times per week concomitantly with Cis-Platin, Navelbine and Docetaxel. Eligibility criteria include: proven HNC not treated before, good performance status, normal bone marrow, liver and renal function, age bellow 60. The regimen is proposed as follows: Cis-Platin i.v. 70 mg/m2 on day 1, 22, 43, 64, Navelbine 20 mg/m2 i.v. on day 1, 8, 22, 29, 43, 50, 64 and Docetaxel 30 mg/m2/week or as 1-h infusion of 60 mg/m2 in each 7 days of RT, Ethyol 1000 mg i.v. on day 1, 22, 43 and 250 mg on day 23–42. Radiotherapy 1,7 Gy per fraction continuously on day 23–42 and 44–63. Different treatment schedules of Docetaxel could be used on the basis of cellular activity for a given tumour. So, biopsy should be obtained for analysis of pretreatment levels of apoptosis and oncogenes such as p53, Bax, Bcl-2