Different Radiation Dose of Neoadjuvant Chemoradiation Followed by Surgery in Treating Patients with Locally Advanced, Resectable Thoracic Esophageal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 2
- 主要终点
- Progression free survival
研究概览
简要总结
Esophageal cancer is one of the most common cancers worldwide, while more than half new cases and deaths occurred in China. Surgery is the main curative treatment for this disease, the 5-year survival of EC remains poor, since most diseases are diagnosed at advanced stages.
In last decades, several large clinical trials and meta-analyses have demonstrated that neo-adjuvant chemoradiotherapy followed by surgery can significantly increase the overall survival of patients with EC compared with surgery alone, while no effect of nCRT was apparent on postoperative health-related quality of life . However, the optimal radiation dose and surgery timing are still unknown.
The investigators hypothesize that patients who receive higher dose (50.4Gy/28F) of neoadjuvant chemoradiation will have better pathologic response and progress-free survival compared to lower dose (41.4Gy/23F) of chemoradiation followed by surgery.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age:18-70 years
- •Histologically verified squamous carcinoma of the thoracic esophagus.
- •Patients with performance status 0-1 according to the Eastern Cooperative Oncology Group (ECOG) scale at the pre CRT evaluation and judges to be fit for surgery at the pre and post CRT evaluations.
- •Tumors should be resectable or potentially resectable and without distant metastasis, as assessed before neoadjuvant CRT, including clinical stage T2-4N0M0 or T1-4N1M0 according to the 6th AJCC system.
- •Joined the study voluntarily and signed informed consent form
- •No surgical contraindications
- •No serious system dysfunction and immuno-deficiency, Adequate organ function including the following: Hemoglobin ≥10 g/dL, 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
- •Cervical esophageal cancer (The upper end of the lesion is in the esophagus of the cervical segment).
- •Patients with biopsy (by endoscopic ultrasound, laparoscopy, or laparotomy) proven metastatic supraclavicular or celiac nodes are ineligible.
- •Invasion of the tracheobronchial tree or aorta
- •Tracheoesophageal fistula
- •Concurrent pregnancy or lactation
- •Severe diabetes mellitus with poor blood glucose control
- •History of a second malignancy
- •Patients being unable to undergo esophageal reconstruction with gastric tube, due to prior surgery.
- •Patients undergoing esophageal reconstruction with jejunum.
- •Patients have allergy reaction or contraindications to taxanes.
结局指标
主要结局
Progression free survival
时间窗: 2 year
Time from randomization to tumor progression or any deaths
次要结局
- Complete pathological response rate(analysis is completed 4 weeks after surgery)
- Treatment failure pattern(2 year)
- Overall survival(5 year)
- R0 resection rate in each arm(analysis is completed 4 weeks after surgery)
- Postoperative complications in each study arm(30 and 90 days after surgery)
研究者
Qixun Chen
Director, Head of thoracic surgery
Zhejiang Cancer Hospital