Lymphocyte-sparing Thoracic Radiotherapy vs Conventional Radiotherapy for Esophageal Squamous Cell Carcinoma Treated With Neoadjuvant Therapy: an Open Label, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 212
- 试验地点
- 2
- 主要终点
- acute grade 3/4 lymphopenia
研究概览
简要总结
Esophageal squamous cell carcinoma (ESCC) is one of the most aggressive malignant tumors. Although neoadjuvant chemoradiotherapy combined with surgery has significantly improved the survival rate of patients with locally advanced esophageal cancer, approximately half of the patients will experience local regional recurrence or distant metastasis. Lymphocytes are crucial immune cells in the human body, playing a key role in combating infections and tumor development. In recent years, an increasing body of research has indicated that lymphocyte depletion is a significant factor associated with poor prognosis in various solid tumors, including esophageal cancer. The lymphocyte depletion caused by radiotherapy has garnered considerable attention from oncologists. However, there is still a lack of prospective clinical research data on lymphocyte protection in thoracic tumors. Therefore, this study aims to provide high-level evidence from evidence-based medicine regarding the correlation between lymphocyte depletion and prognosis in esophageal cancer patients, offering more effective strategies and methods to improve the outcomes of neoadjuvant chemoradiotherapy for esophageal cancer.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are able to understand and are willing to participate in the trial, and a signed consent form can be obtained;
- •Pathologically confirmed esophageal squamous cell carcinoma;
- •locally advanced ESCC (cT3-4 or N+);
- •the age of patients should be more than 18 years, and less than 80 years;
- •aged between 18 and 80 years;
- •KPS score of patients should be more than 80
排除标准
- •diagnosis of metastatic esophageal cancer;
- •Patient refuses to receive systemic drug treatment;
- •clinical diagnosis of pleural metastasis or malignant pleural effusion;
- •Pregnant or breastfeeding women;
- •Severe non-cancerous medical comorbidities that affect the implementation of radiotherapy.
研究组 & 干预措施
conventional radiotherapy
ensure coverage of the PTV (Planning Target Volume) and limit the doses to the heart, bilateral lungs, and spinal cord to meet the required dose constraints. do not limits the dose for lymphocyte-related organs
lymphocyte-sparing radiotherapy
Firstly, ensure coverage of the PTV (Planning Target Volume). Secondly, limit the doses to the heart, bilateral lungs, and spinal cord to meet the required dose constraints. While maintaining target coverage and traditional OAR (Organs At Risk) dose constraints, also address dose limits for the TVB1-12 thoracic vertebral bodies, ribs, spleen, and major thoracic blood vessels to protect the lymphocyte
结局指标
主要结局
acute grade 3/4 lymphopenia
时间窗: 1 months after surgery
from treatment to 1 months after completion of neoadjuvant chemoradiotherapy
次要结局
- recurrence-free survival(2 year)
- Overall survival(3 years)
- recurrence-free survival(2 year)
- Lymphocyte-sparing radiotherapy plan pass rate in lymphocyte-sparing group(within 1 week after completion of neoadjuvat radiotherapy plan;)
- Incidence of grade 3 or higher hematologic toxicity(from neoadjuvant chemoradiotherapy to 1 monther after completion of neoadjuvant chemoradiotherapy)
- Pathological complete response rate (pCR)(1 months after surgery)
- R0 resection rate(1 month after surgery)
- Postoperative complications(1 month after surgery)
研究者
QIWEIXIANG
Deputy Chief Physician
Ruijin Hospital