NCT04397341已完成2 期
A Phase II Study of Biweekly Induction Regimen With Docetaxel, Cisplatin and Fluorouracil for Patients With Locally Advanced Squamous Cell Carcinoma of Head and Neck
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 主要终点
- Response rate after induction chemotherapy
研究概览
简要总结
This study aimed to assess the efficacy and safety for biweekly TPF as induction chemotherapy for locally advanced head and neck cancer
详细描述
After being informed the study and potential risk, patients was provided written informed consent prior to initiating therapy. The chemotherapy regimen including docetaxel, cisplatin, 5-fluorouracil, and leucovorin was administered every 14 days for six cycles or until disease progression or intolerant treatment toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has histopathologically or cytologically confirmed diagnosis of stage 3 or 4 squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx.
- •The patient has local advanced, and no distant metastatic, and unresectable disease.
- •The patient has measurable or valuable disease. 4 Age ≥ 20 years.
- •ECOG performance status 0, 1 or 2 at study entry.
- •Life expectancy ≥ 3 months.
- •The patient must have adequate organ function, defined as: 7a Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; Platelets ≥ 100 x 109/L; Hemoglobin
- •9.0 g/dL. 7b Total Bilirubin ≤ 1.5 times upper limit of normal (ULN); Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN. 7c Alkaline phosphatase ≤ 2.5 x ULN. 7d Serum creatinine ≤ 1 x ULN or creatinine clearance ≥ 60 mL/min/1.73 m
- •Signed informed consent. 9 Women of child-bearing potential and men must be willing and able practice adequate contraception prior to study entry and for the duration of study treatment.
排除标准
- •The patient had previous chemotherapy or radiotherapy for squamous cell carcinoma of head and neck.
- •The patient has uncontrolled disorder(s), serious illness or medical condition(s) is/are not be enrolled to study that be confirmed by investigator.
- •Previous or concurrent malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated and without evidence of recurrence for at least 3 years prior to the study.
- •Peripheral neuropathy > Grade
- •The patient is pregnant or breastfeeding.
研究组 & 干预措施
biweekly TPF induction
Experimental
Docetaxel: 50 mg/m2 Cisplatin : 50 mg/m2 5-fluorouracil : 2,500 mg/m2 for 40-48 hrs Leucovorin: 250 mg/m2
干预措施: docetaxel, cisplatin, fluorouracil (Drug)
结局指标
主要结局
Response rate after induction chemotherapy
时间窗: through study completion, an average of 1 years
CT and PET scan according to the RECIST 1.1 criteria.
次要结局
- Progression survival(Through study completion, an average of 6 months)
- Overall survival(Through study completion, an average of 6 months)
- Adverse event(through study completion, an average of 6 months)
研究者
Ching Yun Hsieh
Division of Hematology and Oncology, Department of internal medicine
China Medical University Hospital
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