Study of TPF (Docetaxel, Cisplatin, 5-fluorouracil) Induction Chemotherapy Followed by Surgery and Radiotherapy in Patients With Locally Advanced and Resectable Oral Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Survival rate
研究概览
简要总结
Induction chemotherapy is regarded as an effective way to reduce or downgrade the locally advanced or aggressive cancers, and to improve the chance of eradication of the locoregional lesions by radical surgery and/or radiotherapy. However, there are still debates on the clinical value of induction chemotherapy for patients with advanced and resectable oral squamous cell carcinoma. The hypothesis of this study is that the induction chemotherapy of TPF (docetaxel, cisplatin, and 5-fluorouracil) protocol could benefit the patients with locally advanced oral squamous cell carcinoma. The endpoints of this study are the survival rate, local control, and safety.
详细描述
The primary endpoint of this study is the survival rate (2, 3, 5 years) after induction chemotherapy followed by surgery and radiotherapy. The second endpoint of this study is locoregional control rates (1, 2 years), and the safety.
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
- •Written informed consent prior to any study activities
- •Age 18-75 years old
- •Histological biopsy confirming oral squamous cell carcinoma (tongue, gingiva, buccal mucosa, floor of mouth, palate, and retromolar region)
- •Clinical stage III/IVA (T1-2, N1-2, M0 or T3-4, N0-2, M0, UICC 2002), resectable lesions
- •Karnofsky performance status (KPS) > 60
- •Adequate hematologic function: white blood cell > 3,000/mm^3, hemoglobin > 8g/L, platelet count > 80,000/mm^3
- •Hepatic function: ALAT/ASAT < 2.5 times the upper limit of normal (ULN), bilirubin < 1.5 times ULN
- •Renal function: serum creatinine < 1.5 x ULN
- •Life expectancy ≥ 6 months
排除标准
- •Evidence of distant metastatic disease and other cancers
- •Surgical procedure of the primary tumor or lymph nodes (except diagnostic biopsy) before study treatment
- •Previous radiotherapy for the primary tumor or lymph nodes
- •Prior chemotherapy or immunotherapy for the primary tumor
- •Other previous malignancy within 5 years
- •Systematic diseases history of severe pulmonary or cardiac diseases
- •Creatinine Clearance < 30 ml/min
- •Legal incapacity or limited legal capacity
- •Pregnancy (confirmed by serum or urine β-HCG) or lactation period
研究组 & 干预措施
TPF induction chemotherapy
Induction chemotherapy before surgery: docetaxel, cisplatin, and 5-fluorouracil.
干预措施: TPF induction chemotherapy (Drug)
结局指标
主要结局
Survival rate
时间窗: Up to 5 years
To evaluate the survival rate after TPF induction chemotherapy followed by surgery and radiotherapy.
次要结局
- local control(Up to 5 yeas)
- Number of participants with adverse events(Up to 5 years)
研究者
Lai-ping Zhong
Ninth People's Hospital, School of Medicine
Shanghai Jiao Tong University School of Medicine