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临床试验/NCT05496270
NCT05496270已完成不适用

Surgery Alone Versus Neoadjuvant Treatment Followed by Surgery For MRI-defined T3 Mid-low Rectal Cancer: A Retrospective Cohort Study

Sun Yat-sen University0 个研究点目标入组 1,509 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,509
主要终点
3-year diseases free survival

研究概览

简要总结

Neoadjuvant treatments (nCRT) are becoming the standard treatment for patients with stage II or stage III mid-low rectal cancer. In fact, with the introduction of total mesorectal excision, the local recurrence has been reduced significantly. Recently few studies have shown that surgery alone is enough for patients with T3 rectal cancer. These issues raised the question of whether nCRT is needed for all T3 rectal cancer patients. Therefore, this study was designed to compare the long-term oncological outcomes between surgery and surgery following nCRT among patients with MRI-defined T3, clear MRF mid-low rectal cancer.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Eighteen- to eighty-year-old patients.
  • T3 rectal cancer with clear mesorectal fascia (MRF),
  • within 12 cm from the anal verge at initial diagnosis by magnetic resonance imaging (MRI)

排除标准

  • emergency surgery due to bleeding, perforation, and bowel obstruction,
  • recurrent rectal cancer,
  • inflammatory bowel disease,

结局指标

主要结局

3-year diseases free survival

时间窗: 3 years after surgery

次要结局

  • 3-year overall survival rate(3 years after surgery)
  • Number of participants with surgical complications(30 days after surgery)
  • Margin-free (R0)resection rate(Immediately after the surgery)
  • Local recurrence rate(3 years after the surgery)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanhong Deng

Professor

Sun Yat-sen University

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