跳至主要内容
临床试验/NCT05460403
NCT05460403Unknown不适用

Adjuvant Radiotherapy for Patients With Esophageal Squamous Cell Carcinoma After R0 Resection

Chinese Academy of Medical Sciences1 个研究点 分布在 1 个国家目标入组 3,591 人开始时间: 2022年4月23日最近更新:
适应症

试验速览

阶段
不适用
入组人数
3,591
试验地点
1
主要终点
Overall survival (OS)

研究概览

简要总结

This retrospective study is exploring the treatment effect and toxicity of adjuvant radiotherapy in patients diagnosed with esophageal squamous cell carcinoma after R0 resection.

详细描述

Surgery is one of the most important curative approaches for esophageal cancer. In real-world clinical practice, over 50% of the patients receiving surgical resection as primary management. For patients treated with surgical resection without adjuvant therapy, the probability of local-regional recurrence ranged from 23.0% to 56.5%, accounting for 55.6%-84.5% of the disease recurrence. Once encountering disease recurrence, the subsequent prognosis could be dismal. The median survival time after postoperative disease recurrence ranged from 3 to 8 months. Postoperative radiotherapy (PORT) was one of the potential topical treatment approaches prolonging local-regional recurrence time or moreover, attaining superior disease-free survival (DFS) or overall survival (OS) in selected patients. It is essential to identify patients potentially benefit from PORT. Besides, there were few studies evaluating the impact of postoperative radiation dose to survival outcomes in patients receiving PORT. Whether the PORT-related local-regional recurrence free survival (LRFS) enhancement could convert to OS or DFS improvement is still vague. The current study aimed at evaluating the value of PORT in patients diagnosed with esophageal squamous cell carcinoma after R0 resection.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pathologically diagnosis of esophageal cancer
  • Complete resection (R0 resection)

排除标准

  • Diagnosed with other malignancy within 5 years before surgery
  • Encountered recurrence or port-site implantation receiving palliative-intended radiotherapy
  • Diagnosed with adenosquamous carcinoma or basal cell-like carcinoma
  • Treated with PORT with uncertain radiation dose
  • Treated with PORT with radiation dose > 60Gy

结局指标

主要结局

Overall survival (OS)

时间窗: up to 5 years

From the date of surgery to the date of death or the most recent follow-up.

次要结局

  • Disease-free survival (DFS)(up to 5 years)
  • Local-regional recurrence-free survival (LRFS)(up to 5 years)
  • Distant metastasis (DM)(up to 5 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zefen Xiao

Prof.

Chinese Academy of Medical Sciences

研究点 (1)

Loading locations...

相似试验