JPRN-jRCTs031190028已完成2 期
A phase II study of chemoradiotherapy with weekly carboplatin for head and neck squamous cell caricinoma ineligible for cisplatin
eki Yushi0 个研究点目标入组 30 人开始时间: 2019年5月24日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
Concurrent chemoradiotherapy with low-dose weekly carboplatin showed favorable feasibility, efficacy and acceptable safety for cisplatin ineligible patients with head and neck squamous cell carcinoma. These results suggested that concurrent chemoradiotherapy with weekly carboplatin can be a promising treatment option for head and neck squamous cell carcinoma patients who are unsuitable for standard therapy.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 90age old（—）
- 性别
- All
入选标准
- •1)Pathologic or cytologic diagnosis of head and neck squamous cell carcinoma treated with radical chemoradiotherapy, ie, whole-neck irradiation including bilateral levels II-IV
- •2)Measurable or evaluable lesions
- •3)Over 20 and less than 75 years with moderate renal dysfunction (over 30 and less than 60ml/min of eGFR)
- •4)Over 75 and less than 90 years old with over 40ml/min of eGFR
- •5)Performance status(PS) 0-2
- •6)Adequate organ functions defined as indicated below before registration in 14 days
- •White blood cells >3,000/ mm3
- •Neutrophilic >1,500/mm3
- •Blood platelet >100,000/mm3
- •Total bilirubin less than 2 times as standard
- •AST and ALT less than 2 times as standard
- •7)Written informed consent
排除标准
- •1)Past history of serious drug hypersensitivity
- •2)Presence of other cancer
- •3)Clinically problematic infectious disease
- •4)Severe complication that might affect treatment (eg. emphysema or interstitial pneumoniae)
- •5) Nonradical treatment indicated
- •6) Continuous administration of steroid or immunosuppressant
- •7) Pregnant or nursing women and those with the possibility of pregnancy
- •8) Refusal to birth control during participation
- •9Mental or neurologic disease that might affect participation
- •10)Participation judged by physician to be inadvisable
研究者
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