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

• Conditions: Stage II Colon Cancer; Stage III Colon Cancer; Adjuvant Therapy

• Registration Number: NCT03958435
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-09
• Study First Submitted: 2018-12-25
• Study First Submitted QC: 2019-05-19
• Study First Posted: 2019-05-22
• Status Verified: 2021-05
• Last Update Submitted: 2021-07-14
• Last Update Posted: 2021-07-15
• Primary Completion: 2022-10-15
• Study Completion: 2023-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	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	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	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

Trial Locations

Locations (3)

Jiangsu Province People Hospital; 🇨🇳 Nanjing, Jiangsu, China

Changhai Hospital of Shanghai; 🇨🇳 Shanghai, Shanghai, China

SAHZU; 🇨🇳 Hangzhou, Zhejinag, China