A Prospective, Single-arm Study of Simultaneous Modulated Accelerated Radiotherapy Combined With S-1/DDP for Elderly Esophageal Squamous Cell Carcinoma.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Clinical response rate
研究概览
简要总结
This Prospective, single-arm Phase Ⅱ study is to determine the efficacy and safety of Once-daily Simultaneous Modulated Accelerated Radiotherapy combined with S-1/DDP for geratic esophageal squamous cell carcinoma patients.
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 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically or cytologically confirmed esophageal squamous cell carcinoma.
- •Stage II-IVa ESCC confirmed by endoscopic ultrasonography(EUS) and imaging studies.
- •Aging from 70 to
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Charlson's weighted index of comorbidities (WIC) ≤4；
- •White blood cell count ≥4×109 /L, neutrophile granulocyte count≥1.5×109 /L, platelet count≥100×109 /L, hemoglobin ≥100 g /L, serum creatinine and bilirubin 1.5 times less than the upper limits of normal (ULN),aminotransferase two times less than the ULN.
- •Weight loss ≤15% within the past half year.
- •Forced expiratory volume in 1 s≥ 1 L.
- •Patients and their family signed the informed consents.
排除标准
- •Previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ.
- •Already received antineoplastic therapy,including chemotherapy, radiotherapy or operation.
- •Any contraindication for chemotherapy or radiotherapy(such as a myocardial infarction within 6 months,immunosuppressive therapy,symptomatic heart disease,including unstable angina pectoris, congestive heart failure,and uncontrolled arrhythmia.)
- •Malignant pleural effusion or pericardial effusion.
- •Weight loss >10% within the past 3 months.
- •Recruited in other clinical trials within 30 days
- •Drug addiction, long-term alcohol abuse and AIDS patients.
- •Uncontrollable epileptic attack or psychotic patients without self-control ability.
- •Severe allergy or idiosyncrasy.
- •Not suitable for this study judged by researchers.
研究组 & 干预措施
SMART & S-1/DDP
Patients in experimental group receive daily simultaneous modulated accelerated radiotherapy combined with DDP and S-1.
干预措施: SMART (Radiation)
SMART & S-1/DDP
Patients in experimental group receive daily simultaneous modulated accelerated radiotherapy combined with DDP and S-1.
干预措施: DDP (Drug)
SMART & S-1/DDP
Patients in experimental group receive daily simultaneous modulated accelerated radiotherapy combined with DDP and S-1.
干预措施: S-1 (Drug)
结局指标
主要结局
Clinical response rate
时间窗: 2-year
the percentage of patients who had partial remission or complete remission after chemoradiotherapy
次要结局
- grade 3 or 4 toxicities according to CTCAE4.0(1 year after radiochemotherapy)
- progression-free survival(3-year)
- overall survival(3-year)
研究者
Hui Liu
professor
Sun Yat-sen University