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临床试验/NCT03958435
NCT03958435Unknown不适用

Real-world Retrospective Data Analysis of Adjuvant Therapy for Patients With Stage II-III Colon Cancer After Radical Surgery

Second Affiliated Hospital, School of Medicine, Zhejiang University3 个研究点 分布在 1 个国家目标入组 20,000 人开始时间: 2018年11月9日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20,000
试验地点
3
主要终点
Percentage of Participants with treatment-related Adverse Events as Assessed by CTCAE v4.0 for adjuvant therapy for stage II and stage III colon cancer

研究概览

简要总结

Background:

  1. . The incidence and mortality of colon cancer are high in China and in the world.
  2. . The treatment of many patients in the real world is not standardized, and there are problems such as over-treatment or under-treatment. To explore the adjuvant treatment of colon cancer in the Chinese population, this study will retrospectively analyze real-world data on adjuvant therapy for colon cancer in Chinese patients after radical surgery.

The purpose of research:

  1. . Current status of adjuvant therapy for stage II-III colon cancer in the real world: chemotherapy regimen, chemotherapy time, efficacy, safety, etc.
  2. . Comparison of efficacy and safety of different adjuvant chemotherapy time (<3 months vs. >=3 months) in high-risk stage II and III colon cancer patients in the real world
  3. . Comparison of efficacy and safety of different adjuvant chemotherapy regimens (XELOX vs. FOLFOX) in high-risk stage II and III colon cancer patients in the real world

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

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

入选标准

  • Patients who are sick after January 2010
  • Age is older than 18
  • Surgical pathology confirmed TNM stage II-III (AJCC 7th edition) colon cancer

排除标准

  • Combine other tumors
  • Pathological information is not clear
  • Researchers believe that other reasons are not suitable for enrollment

结局指标

主要结局

Percentage of Participants with treatment-related Adverse Events as Assessed by CTCAE v4.0 for adjuvant therapy for stage II and stage III colon cancer

时间窗: From patients after stage II and stage III colon cancer radical resection to until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.

Percentage of Participants with treatment-related Adverse Events as Assessed by CTCAE v4.0 for adjuvant therapy for stage II and stage III colon cancer

Percentage of patients with chemotherapy regimen for adjuvant therapy after stage II and stage III colon cancer

时间窗: From patients after stage II and stage III colon cancer radical resection to until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.

Percentage of patients with chemotherapy regimen for adjuvant therapy after stage II and stage III colon cancer

Percentage of patients with different chemotherapy time for adjuvant therapy for stage II and stage III colon cancer

时间窗: From patients after stage II and stage III colon cancer radical resection to until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months.

Percentage of patients with different chemotherapy time for adjuvant therapy for stage II and stage III colon cancer

次要结局

未报告次要终点

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (3)

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