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

Stage III Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03958435
• Other study ID #: REDUCE201809
• Status: Recruiting
• Start date: November 9, 2018
• Est. completion date: December 15, 2023

Study information

• Verified date: May 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Ying Yuan, Ph.D&MD
• Phone: +86-571-87784795
• Email: yuanying1999[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: December 15, 2023
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who are sick after January 2010

• Age is older than 18

• Surgical pathology confirmed TNM stage II-III (AJCC 7th edition) colon cancer

Exclusion Criteria:

• Combine other tumors

• Pathological information is not clear

• Researchers believe that other reasons are not suitable for enrollment

Related Conditions & MeSH terms

• Adjuvant Therapy
• Colonic Neoplasms
• Stage II Colon Cancer
• Stage III Colon Cancer

Locations

Country	Name	City	State
China	SAHZU	Hangzhou	Zhejinag
China	Jiangsu Province People Hospital	Nanjing	Jiangsu
China	Changhai Hospital of Shanghai	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with chemotherapy regimen for adjuvant therapy after stage II and stage III colon cancer	Percentage of patients with chemotherapy regimen for adjuvant therapy after stage II and stage III colon cancer	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.
Primary	Percentage of patients with different chemotherapy time for adjuvant therapy for 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	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.
Primary	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 Participants with treatment-related Adverse Events as Assessed by CTCAE v4.0 for adjuvant therapy for stage II and stage III colon cancer	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.