A Phase Ⅱ Study of S-1 With Concurrent Radiotherapy in Elderly Esophageal Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- response rate
研究概览
简要总结
To investigate the efficacy and toxicity of S-1 with concurrent radiotherapy in older patients with esophageal cancer.
详细描述
Older patients with esophageal cancer have been correlated with poor prognosis because of having little chance to receive aggressive local therapy, including concurrent chemoradiotherapy. In this phase II trial, the efficacy and toxicity of S-1 with concurrent radiotherapy will be investigated in this setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cytologically or histologically confirmed esophageal carcinoma;
- •ECOG performance status: 0-1;
- •No treatments prior to enrollment;
- •At least one measurable lesion on CT, MRI or esophageal barium exam;
- •Normal functions of heart, lung, liver, kidney and bone marrow;
- •Blood exams qualified for chemotherapy, which included hemoglobulin ≥9 g/dl, neutrophil ≥1.5×109/L and platelet (PLT) ≥100×109/L, creatinine ≤1.5 UNL;
- •Informed consent signed.
排除标准
- •Prior treatments of chemotherapy or irradiation;
- •Poor bone marrow, liver and kidney functions, which would make chemotherapy intolerable;
- •Contraindication for irradiation: complete obstruction of esophagus, deep esophageal ulcer, fistula to mediastinum, or haematemesis;
- •Participating in other clinical trials;
- •Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities;
- •The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin.
研究组 & 干预措施
Radiotherapy and S-1 arm
Radiotherapy will be delivered with a daily fraction of 1.8 Gy to a total dose of 50.4 Gy. Preplanned concurrent S-1 (70mg/m²/day) will be administered on Day 1 for 14 days, every 3 weeks. After dCRT, maintenance S-1 will be given up to two cycles.
干预措施: S-1 (Drug)
Radiotherapy and S-1 arm
Radiotherapy will be delivered with a daily fraction of 1.8 Gy to a total dose of 50.4 Gy. Preplanned concurrent S-1 (70mg/m²/day) will be administered on Day 1 for 14 days, every 3 weeks. After dCRT, maintenance S-1 will be given up to two cycles.
干预措施: radiotherapy (Radiation)
结局指标
主要结局
response rate
时间窗: week 4
Response rate will be done after 4 weeks following the last radiotherapy session.
次要结局
- Progression-free survival(year 0 - year 2)
- Overall survival(year 0 - year 2)
- Acute and late toxicities assessed based on the common toxicity criteria for adverse events version 3.0 (CTCAEv3.0)(year 0 - year 1)
研究者
Shiliang Lv
MD
Zhejiang Provincial People's Hospital