NCT02556762进行中（未招募）3 期
Phase III Randomized Controlled Trial of Definite Chemoradiotherapy in Patients With Esophageal Cancer: Simultaneous Modulated Accelerated Boost Versus Standard Dose Radiotherapy
Chuangzhen Chen1 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2015年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
This randomized phase III trial is to compare simultaneous modulated accelerated boost with standard dose radiotherapy given together with chemotherapy in treating patients with esophageal squamous cell carcinoma.
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
- Single (Outcomes Assessor)
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
- •Histologic proof of primary squamous cell carcinoma of the esophagus.
- •Primary disease at cervical, upper or middle thoracic esophagus
- •T1-4, N any, M0 (except supraclavicular lymph node).
- •Age≥18 & ≤
- •ECOG score 0-
- •Platelets ≥ 150,000, Hgb ≥ 10 gm%, ANC ≥ 1500, serum creatinine ≤ 1.5 mg/dl.
- •Adequate liver function.
- •Patients with prior malignancy are eligible if disease-free ≥ 5 years.
- •No prior chest radiotherapy, systemic chemotherapy or major esophageal surgery.
- •Signed study-specific informed consent form prior to study entry.
排除标准
- •Patients with tracheo-esophageal fistula.
- •Patients with invasion into mucosa of trachea or major bronchi.
- •Patients with uncontrolled serious medical or mental illnesses.
- •Prior RT that would result in overlap of planned RT fields.
- •Pregnancy or women of childbearing potential and men who are sexually active
- •Women who are breastfeeding a baby.
研究组 & 干预措施
SMART boost
Experimental
Radiotherapy with simultaneous modulated accelerated boost
干预措施: Radiotherapy with simultaneous modulated accelerated boost (Radiation)
SMART boost
Experimental
Radiotherapy with simultaneous modulated accelerated boost
干预措施: PF (Drug)
Standard dose RT
Active Comparator
Standard dose radiotherapy
干预措施: Standard dose radiotherapy (Radiation)
Standard dose RT
Active Comparator
Standard dose radiotherapy
干预措施: PF (Drug)
结局指标
主要结局
Overall survival
时间窗: 2 years
次要结局
- Local-regional control(2 years)
- Acute and late toxicities using CTCAE v4.0(2 years)
- Disease-free survival(2 years after randomization)
- Biomarkers(2 years)
- Quality of life as measured with EQ-5D(2 years)
- Distant metastasis-free survival(2 years)
- Quality of life as assessed with FACT-E(2 years)
研究者
Chuangzhen Chen
M.D
Shantou University Medical College
研究点 (1)
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