CTRI/2014/07/004791已完成2 期
A prospective randomized phase II Study comparing metronomic chemotherapy with chemotherapy (single agent cisplatin),in patients with metastatic, relapsed or inoperable squamous cell carcinoma of Head and Neck
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Metasatatic ,recurrent or locally advanced head and neck cancers deemed unsuitable for loco-regional treatment.
- •Histologically proven squamous cell cancer
- •Age group 18-70years
- •Karnofsky performance status more than or equal to 70
- •Normal pretreatment haemaotological and biochemical parameters as defined below
- •Haemoglobin:8-18mg/dl
- •Absolute Neutrophil count more than 1000/mm3
- •Total leucocyte count 3000-10,000/mm3
- •Platelet count -1-4lakhs/mm3
- •S urea and S creatnine below 45 and 1.2 respectively.
- •Serum Creatinine clearance more than 60
- •Fasting blood sugar less than 120
- •Baseline Liver function test within twice the normal limits
排除标准
- •Primary in thyroid,salivary gland or nasopharynx
- •patients with significant and uncontrolled comorbid conditions like DM,Hypertension,COPD,active tuberculosis and HIV positive patients
- •Patients who have received cisplatin within last 3 months
- •serological positive for HIV,HCV and HBV
研究者
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