A Phase II Study of Daily Low-Dose of Nedaplatin (CDGP:Cis-Diammine-Glycolatoplatinum) and Continuous Infusion of 5-FU Combined With Radiation for the Treatment of Esophageal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
The purpose of this study is to clarify efficacy and toxicity of daily low-dose Nedaplatin (CDGP) and continuous infusion of 5-FU combined with radiation in patients with esophageal squamous cell carcinoma.
详细描述
The tumor stages and disease grades were classified according to the TNM classification (sixth edition) of the International Union against Cancer (UICC). These were determined conventionally by computed tomography (CT) of the neck, chest and abdomen, bone scan, endoscopic ultrasonography (EUS), endoscopy and esophagography.
Low-dose of Nedaplatin (CDGP) 10 mg/body/day was daily administered on day 1-5, 8-13, 15-19, 22-26 and 5-FU 500 mg/body/day was continuously administered on day 1-5, 8-13, 15-19, 22-26. Fractionated radiotherapy was performed from day 1 and a total dose of 50-60 Gy was delivered at the rate of 1.8-2.0 Gy per fraction. Serotonin receptor antagonist was preventively given as an antinauseant just before the administration of Nedaplatin.
Tumor response was assessed according to the Response Evaluation Criteria In Solid Tumors (UICC, 2002). Toxicities were graded according to the Common Terminology Criteria for Adverse Events v3.0 (CTCAE). Survival was calculated from the start of chemoradiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newly diagnosed cases histologically as squamous cell carcinoma,
- •a performance status 0 to 2,
- •white blood cells >3,000/microL,
- •platelets >100,000/microL,
- •serum total bilirubin <2.0 mg/dl,
- •serum transaminase <3 times the upper normal limit,
- •serum creatinine <1.5 mg/dl,
- •creatinine clearance >60 ml/min
排除标准
- •serious cardiac disease
- •prior chemotherapy and radiotherapy
研究组 & 干预措施
1
Chemoradiotherapy
干预措施: CDGP/5-FU combined with radiation (Drug)
1
Chemoradiotherapy
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Response rate
时间窗: 3 months
次要结局
- Adverse events(every 3-6 months)
- Survival rate(every 3-6 months)