A prospective randomized Study comparing oral metronomic chemotherapy with intravenous chemotherapy, in patients with metastatic, relapsed or inoperable squamous cell carcinoma of Head and Neck.

Tata Memorial Centre0 个研究点目标入组 422 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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•Cytologically or pathologically proven squamous cell carcinoma of head and neck. Treatment of the head and neck cancer with palliative intent
•Distant metastases from head-neck primary
•Recurrent head-neck cancer presently not amenable to surgery or irradiation (are treated adequately at initial diagnosis)
•Loco-regionally advanced stage disease deemed unsuitable for definitive surgery or radiotherapy (Patient could still be eligible for palliative radiotherapy for symptom relief)
•2. Subjects between the ages of 18 - 70 yrs with Karnofsky performance scores >=70
•3.Pretreatment normal hematological and biochemical parameters as defined below:
•1.Hemoglobin : >= 8 mg/dL
•2.Absolute neutrophil count >1500
•3.Total Leucocyte counts > 3000
•4.Platelet counts: 100,000 - 1000,000 /mm3
•5.Creatinine Clearnce more than or equal to 45 ml/min.
•4. Baseline liver function test within twice the normal limit for serum bilirubin.Patients should have signed the informed consent form and must be available for follow-up as outlined below.

•Exclusion Criteria:
•1. Evidence of primary in Thyroid or salivary gland or nasopharynx
•2. Patients with significant and uncontrolled co morbid conditions e.g. Diabetes Mellitus, Hypertension, COPD ,active Tuberculosis and HIV positive patients
•3. Patients who have received cisplatin within last 3 months
•4. Serological positive for HIV,HBV & HCV

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