NCT02923258已完成2 期
Postoperative Radiation and Concurrent Chemotherapy With Weekly Docetaxel Versus Cisplatin in Patients With High-risk Oral Cavity Cancer: a Randomized Phase II Clinical Trial
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University1 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2018年4月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Disease-free survival (DFS)
研究概览
简要总结
This is a randomized,controled, phase II, open label study of postoperative concurrent chemoradiotherapy with Docetaxel versus Cisplatin for high-risk squamous cell carcinoma of the oral cavity cancer.The primary purpose of this study is to evaluate the efficacy of concurrent chemoradiotherapy with docetaxel in OCC patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Histologically confirmed squamous cell carcinoma of the oral cavity
- •Gross total resection, with pathology demonstrating one or more of the following risk factors:
- •Histologic extracapsular nodal extension
- •Histologic involvement of ≥ 2 regional lymph nodes
- •Invasive cancer is seen on microscopic evaluation of the resection margin, with no evidence of gross tumor residual
- •No evidence of distant metastases
- •No synchronous or concurrent head and neck primary tumors
- •Adequate organ function including the following:
- •Absolute neutrophil count (ANC) >= 1.5 * 10^9/l
- •Platelets count >= 100 * 10^9/l
- •Hemoglobin >= 10 g/dl
- •AST and ALT <= 2.5 times institutional upper limit of normal (ULN)
- •Total bilirubin <= 1.5 times institutional ULN
- •Creatinine clearance >= 50 ml/min
- •Serum creatine <= 1 times ULN 7.Signed written informed consent
排除标准
- •Evidence of distant metastasis
- •Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
- •Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
- •Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures 5.Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
研究组 & 干预措施
Control
Active Comparator
Concurrent Chemoradiotherapy With Cisplatinum and IMRT
干预措施: Cisplatin (Drug)
Experimental
Experimental
Concurrent Chemoradiotherapy With Docetaxel and IMRT
干预措施: Docetaxel (Drug)
Experimental
Experimental
Concurrent Chemoradiotherapy With Docetaxel and IMRT
干预措施: IMRT (Radiation)
Control
Active Comparator
Concurrent Chemoradiotherapy With Cisplatinum and IMRT
干预措施: IMRT (Radiation)
结局指标
主要结局
Disease-free survival (DFS)
时间窗: 2 years
次要结局
- Adverse Events (AE)(3 months)
- Overall Survival (OS)(2 years)
- Locoregional failure-free survival (LRFS)(2 years)
- distant metastasis free survival (DMFS)(2 years)
研究者
Guopei Zhu
MD
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
研究点 (1)
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