A Multicenter Phase Ⅲ Trial of Cisplatin Plus Raltitrexed or 5-fluorouracil in Concurrence With Intensity-modulated Radiotherapy (IMRT) for the Treatment of Locoregionally Advanced Head and Neck Squamous Cell Cancer
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This study is a multicenter phase Ⅲ trial. The objective is to compare the efficacy and toxicity of cisplatin plus raltitrexed or 5-fluorouracil in concurrence with IMRT for patients with locoregionally advanced head and neck squamous cell cancer.
详细描述
The objective is to compare the efficacy and toxicity of cisplatin plus raltitrexed or 5-fluorouracil in concurrence with IMRT for patients with locoregionally advanced head and neck squamous cell cancer.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed untreated head and neck squamous cell cancer patients
- •18-70 years
- •Clinical stage: T3-4N0-3M0 or T1-4N1-3M0
- •Hematologic function: WBC ≥ 4.0×109/L, PLT ≥ 80×109/L, Hb ≥ 10mg/dL
- •Renal function: Cr ≤ 1.25×UNL
- •Hepatic function: BIL ≤ 1.5×UNL, ALT/AST ≤ 2.5×UNL
- •Woman and man of childbearing age must adopt contraception
- •With written consent
排除标准
- •Malignant history
- •Pregnant or lactating women
- •With other severe diseases (blood, liver ,kidney or heart diseases)
- •Subjects not suitable for chemo-radiotherapy
- •Without written consent
研究组 & 干预措施
Raltitrexed plus cisplatin
Raltitrexed plus cisplatin and IMRT
干预措施: Raltitrexed (Drug)
Raltitrexed plus cisplatin
Raltitrexed plus cisplatin and IMRT
干预措施: Cisplatin (Drug)
Raltitrexed plus cisplatin
Raltitrexed plus cisplatin and IMRT
干预措施: IMRT (Radiation)
5-fluorouracil plus cisplatin
5-fluorouracil plus cisplatin and IMRT
干预措施: 5-fluorouracil (Drug)
5-fluorouracil plus cisplatin
5-fluorouracil plus cisplatin and IMRT
干预措施: Cisplatin (Drug)
5-fluorouracil plus cisplatin
5-fluorouracil plus cisplatin and IMRT
干预措施: IMRT (Radiation)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: 36 months
次要结局
- Overall Survival (OS)(36 months)
- Percentage of participants experiencing grade 3-5 adverse events(AEs)(36 months)
- Locoregional and distant control rate(36 months)
研究者
Dr. Xia He
Director of Radiation Oncology
Jiangsu Cancer Institute & Hospital