NCT02813967已完成3 期
S-1 Concurrent With Radiotherapy Versus Radiotherapy for Elderly Chinese Patients With Squamous Cell Carcinoma of Esophagus: A Prospective, Randomized, Multi-center Phase-III Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 298
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
This was a randomised, multicenter, phase 3 trial. Patients who were age of 70 years or older with histologically confirmed esophageal cancer were randomly assigned to S-1 concurrent with radiotherapy or radiotherapy alone.The primary endpoint was overall survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytologic diagnosis of esophageal carcinoma
- •ECOG performance status 0-1
- •Age:70-85 years
- •Joined the study voluntarily and signed informed consent form
- •Patients must not have received any prior anticancer therapy
- •Stage Ⅰ-ⅣB（AJCC 2009）
- •Target lesions can be measured according to RECIST criteria
- •No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥9 g/dL, WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L, platelet count ≥100x 109/L, TBIL<1.5 x ULN, ALT and AST ≦ 2.5 x ULN, creatinine ≦ 1.5 x ULN
排除标准
- •Multiple carcinomas of the esophagus,
- •Biopsy-proven invasion of the tracheobronchial tree or tracheoesophageal fistula,
- •Metastatic disease (M1b),
- •A primary tumor that extended to within 2 cm of the gastroesophageal junction,
- •Prior chemotherapy, prior thoracic radiation, surgical resection of the primary tumor,
- •history of a second malignancy other than nonmelanoma skin cancer
研究组 & 干预措施
chemoradiotherapy
Experimental
Radiotherapy 54 Gy was administered in 1.8 Gy fractions 5 times weekly. S-1 70mg/m2 was administered on days 1-14 and 29-42
干预措施: Radiotherapy 54 Gy (Radiation)
chemoradiotherapy
Experimental
Radiotherapy 54 Gy was administered in 1.8 Gy fractions 5 times weekly. S-1 70mg/m2 was administered on days 1-14 and 29-42
干预措施: S-1 (Drug)
Radiotherapy 60 Gy
Active Comparator
Radiotherapy 60 Gy was administered in 2Gy fractions 5 times weekly.
干预措施: Radiotherapy 60 Gy (Radiation)
结局指标
主要结局
Overall survival
时间窗: 5 years
2-year over survival
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(5 years)
- Progression-free survival(5 years)
研究者
研究点 (1)
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