Phase I Study of S-1 Plus Nedaplatin With Concurrent Radiotherapy for Advanced Esophageal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD) of s-1 in combination with nedaplatin and thoracic radiotherapy
研究概览
简要总结
Patients with advanced esophageal cancer will receive thoracic radiation therapy 60Gy over 30 fractions,and concurrent with s-1 and nedaplatin.
详细描述
Purpose: To determine the maximum tolerated dose (MTD) and recommended dose (RD) of S-1 in combination with nedaplatin and thoracic radiotherapy in patients with advanced esophageal Cancer.
Methods: Thoracic radiation therapy was administered in 2Gy fractions five times weekly to a total dose of 60 Gy.Concurrently, nedaplatin was given at a fixed dose of 75 mg/m2 on Days 1, and s-1 was given on Days 1-14,repeated every 4 weeks for four cycles. The dose of s-1 was initially 60 mg/m2/day and gradually increased to determine the MTD and RD of this regimen.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic proof of primary squamous cell or adenocarcinoma of the esophagus
- •Locoregionally advanced carcinoma of esophagus without systemic metastases
- •Zubrod Performance Status 0-1;
- •Patients ≥ 18 years of age;
- •No hypersensitivity to E. coli -derived products;
- •AGC ≥ 1500/mm3, platelets ≥ 150,000/mm3, Hgb ≥ 10 gm%, serum creatinine ≤ 1.5 mg/dl and/or calculated creatinine clearance ≥ 65 cc/min; serum calcium ≤ 11gm/dl;
- •Patients with prior malignancy are eligible if curable non-melanoma skin cancer or cervical cancer in situ or disease free ≥ 5 years;
- •No prior chest or upper abdomen radiotherapy; no prior systemic chemotherapy within the past 5 years; no prior esophageal or gastric surgery;
- •Written informed consent.
排除标准
- •Evidence of tracheoesophageal fistula, or invasion into the trachea or major bronchi.
- •Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (For example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
- •Prior systemic chemotherapy or radiation therapy for esophageal cancer
研究组 & 干预措施
Chemoradiotherapy
Thoracic radiation 60Gy over 30 fractions.Concurrently, nedaplatin was given at a fixed dose of 75 mg/m2 on Days 1, and s-1 was given on Days 1-14,repeated every 4 weeks for four cycles. The dose of s-1 was initially 60 mg/m2/day and gradually increased to determine the MTD and RD of this regimen.
干预措施: S-1, Nedaplatin (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD) of s-1 in combination with nedaplatin and thoracic radiotherapy
时间窗: 3 months per patient
the MTD will be defined as the maximum dose level at which no more than one subject out of six experiences a dose-limiting toxicity (DLT) during treatment.
次要结局
- Objective response rate(dependent upon results)
研究者
JYongling
MD
Zhejiang Cancer Hospital