CTRI/2018/03/012422进行中（未招募）3 期
Concurrent Chemotherapy and External Radiation Therapy:An Open Label Non-Inferiority Phase III Randomized Controlled Trial of Weekly versus ThreeWeeklyCisplatinandRadical Radiotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma - head and neck cancer,chemotherapy,radiotherapy
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
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
- •1.Newly diagnosed, chemo/radiotherapy naÃ?¯ve, biopsy or cytology proven, locally advanced head and neck squamous cell carcinoma excluding nasopharyngeal carcinoma (stage III and IV without distant metastases)
- •2.Patients who are considered suitable for either definitive chemo-radiation after discussion in combined clinic(HN clinic)
- •3.No evidence of distant metastases on clinical examination or on chest x-ray
- •4.Age 18-70 years
- •5.ECOG PS 0-2
- •6.No contraindication to Cisplatin or radiotherapy
- •7.Adequate organ function at time of participation, defined as
- •A. Hematological: Hemoglobin > 9gm/dl, ANC ââ?°Â¥ 1500/cmm3, Platelet ââ?°Â¥100000/cmm3
- •B. Liver Function test: Bilirubin ââ?°Â¤2 x upper limit normal (ULN), AST/ALT/ ALP ââ?°Â¤ 2.5 x ULN
- •C. Renal Function test: Creatinine ââ?°Â¤ 1.5 ULN, Creatinine Clearance ââ?°Â¥60 ml/mins
排除标准
- •1.Uncontrolled concomitant other systemic disease
- •2.History of moderate to severe hearing loss
- •3.History of previous malignancy excluding non-melanoma skin cancers or cervical carcinoma in situ
- •4.Documented Weight loss of more than 15% in last 6 months
- •5.Patients with known HIV, hepatitis B or C infection
- •6.Patients with known distant metastases
研究者
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