A Prospective, Phase Ⅱ Study of S-1 Plus Moderately Hypofractionated Conformal Radiation for Esophageal Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Progression-Free Survival
研究概览
简要总结
This Phase II randomized study is to determine the efficacy and toxicities of moderately hypofractionated conformal radiation combined With S-1 for esophageal squamous cell carcinoma.
详细描述
This Phase II randomized study is to determine the efficacy and toxicities of moderately hypofractionated conformal radiation combined With S-1 for esophageal squamous cell carcinoma.
All patients will receive two cycles of S-1 (40mg/㎡, BID, po) on D1-14, D22-35, combined with thoracic radiotherapy of 60 Gy/24 fractions for GTV and 40 Gy/16 fractions for CTV. The primary end point is progression-free survival, which is the time that passes from the first day of radiotherapy to the date on which disease progresses. Progression-free survival will be calculated and compared using the Kaplan-Meier method.Toxicities will be graded according to CTCAE v. 4.0.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed esophageal squamous cell carcinoma
- •Inoperable stage II-IVa (UICC 2002; sixth edition), confirmed by contrast enhanced computed tomography,endoscopic ultrasonography, barium esophagram, emission computed tomography and/or positron emission tomography/computed tomography.
- •Eastern Cooperative Oncology Group (ECOG) performance status 1-2
- •Estimated life expectancy of at least 12 weeks
- •Charlson comorbidity index.4
- •Adequate bone marrow function: white blood cells grade 0 or 1,absolute neutrophils grade 0 or 1, platelets grade 0, haemoglobin grade 0 or 1
- •Adequate renal function: creatinine grade 0 or 1
- •Adequate liver function: serum bilirubin grade 0 or 1, alanine aminotransferase and aspartate aminotransferase <2 times of the upper normal limit
- •Weight loss.15% during 6 months prior to diagnosis
- •Forced expiratory volume second.1L
排除标准
- •Prior history of malignancy, except for nonmelanoma skin carcinoma or cervical carcinoma in situ
- •Previous anti-tumor therapy, including surgery, chemotherapy or radiotherapy
- •Contraindication for chemotherapy or radiotherapy
- •Malignant pleural or pericardial effusion
- •Women in pregnancy or lactation period
- •Women who has the probability of pregnancy without contraception
- •Weight loss≥15% during 3 months prior to diagnosis
- •In other clinical trials within 30 days
- •Addicted in drugs or alcohol, AIDS patients
- •Uncontrollable seizure or psychotic patients without self-control ability
- •Severe allergy or idiosyncrasy
- •Not suitable for this study judged by researchers
结局指标
主要结局
Progression-Free Survival
时间窗: 3 years
次要结局
- Overall Survival(3 years)
- rate of grade 3-4 radiation esophagitis(1 year)
- rate of grade 3-4 radiation pneumonitis(1 year)
研究者
Hui Liu
Professor
Sun Yat-sen University