Open label, non controlled, non randomized, interventional pilot study to evaluate the response rate after induction therapy with Docetaxel (T) and cisplatin (P) in unresectable locally advanced squamous cell carcinoma of head and neck. - Direct Study

Aventis Pharma Limited0 个研究点目标入组 40 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•(i)histologically confirmed, unresectable locally advanced SCCHN of oral cavity, oropharynx, larynx or hypopharynx in stage IIIâ??IV without evidence of distant metastases
•(ii)no prior chemotherapy or radiation therapy;
•(iii)having at least one measurable lesion in one dimension;
•(iv)age >18 & <65 years with Eastern Cooperative Oncology Group (ECOG) < 1;
•(v)adequate haematological function with neutrophil count P1500/ml, platelets >100,000/ml and haemoglobin >10 g/ml;
•(vi)adequate hepatic function with bilirubin <1• the upper normal limit, GOT and GPT 62.5 the upper normal limit and alkaline phosphatase 65 5 times the upper normal limitthe upper normal limit;
•(vii)renal function within normality with serum creatinine <1.4 mg/dl and creatinine clearance >60 ml/ min calculated by the Cockcroftâ??Gault method.

•(i)Peripheral neuropathy or other serious diseases (unstable ischaemic heart disease, acute myocardial infarction 6 months prior to inclusion, history of significant neurological or psychiatric disorder or active peptic ulcer)
•(ii)Being treated concomitantly with corticosteroids (except as pre-medication)
•(iii)Patients having another type of neoplasm.
•(iv)Previous chemotherapy or radiotherapy
•(v)Any previous definitive surgery for squamous cell carcinoma of head and neck
•(vi)Severe weight loss ( > 20 % of body weight) in the preceding 3 months

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