JPRN-UMIN000025436招募中2 期
Phase II multicenter trial of platinum-cetuximab combined with docetaxel or with 5FU for Japanese patients with recurrent/metastatic squamous cell carcinoma of the head and neck. - TEMPER study
Clinical Research Support Center Kyushu0 个研究点目标入组 180 人开始时间: 2017年3月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 180
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
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Prior systemic chemotherapy (expect as part of a multimodal therapy for locally advaneced disease > 6 months before the trial entry) 2) Prior dose of cisplatin > 300 mg/m2 3) Prior surgery (excluding prior diagnostic biopsy) or irradiation within 4 weeks before registration 4) Simultaneous or metachronous (within 3 years) double cancers (excluding superficial cancer that will be cured by endoscopic mucosal resection) 5) Symptomatic brain metastasis 6) Severe myelosuppression or infections 7) Pulmonary fibrosis, acute lung injury or Intestinal pneumonia 8) Severe and uncontrolled complication (heart failure, pulmonary fibrosis, renal failure, hepatic failure, uncontrolle diabetes mellitus or uncontrolled hypertension) 9) Known hypersensitivity against any components of the trial treatment including excepients 10) Pregnancy or breast feeding 11) Receiving other concomitant anti tumor therapy 12) Previous treatment with cetuximab or monoclonal antibody 13) Positive HBs antigen 14) Decision of ineligibility by a physician
研究者
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