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

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

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 20000

Contacts and Locations

• Study Contact: Name: Ying Yuan, Ph.D&MD; Phone Number: +86-571-87784795; Email: yuanying1999@zju.edu.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • Jiangsu Province People Hospital
      • Contact: Yanhong Gu, MD
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Changhai Hospital of Shanghai
      • Contact: Wei Zhang, MD
  • Zhejinag
    • Hangzhou, Zhejinag, China, 310009
      • Recruiting
      • SAHZU
      • Contact: Ying Yuan, Ph.D & MD; Email: yuanying1999@zju.edu.cn
      • Contact: Ying Yuan; Email: yuanying1999@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

20000 patients diagnosed with stage II-III colon cancer and undergo radical surgery since January 2010.

The demographic analysis of this study will include but limited in：

• Demographic characteristics (age, gender, height, weight),
• Clinical information (Site, TNM(Tumor, regional lymph Node, Metastasis) staging, CEA(Carcinoembryonic Antigen), imaging findings, patient ECOG(Eastern Cooperative Oncology Group)score, PS(Performance Status) score),
• Pathology information (MMR(Mismatch Repair) status, RAS status, BRAF status, HER2 status, Lymph node, Number of detections, Nerve infiltration, Vascular invasion, Histological type, etc.)

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2018
• Primary Completion (Anticipated): October 15, 2022
• Study Completion (Anticipated): December 15, 2023

Study Registration Dates

• First Submitted: December 25, 2018
• First Submitted That Met QC Criteria: May 19, 2019
• First Posted (Actual): May 22, 2019

Study Record Updates

• Last Update Posted (Actual): July 15, 2021
• Last Update Submitted That Met QC Criteria: July 14, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Adjuvant therapy; Chemotherapy regimen; Current status; Chemotherapy time; Stage II-III colon cancer; RWS(Real World Study)
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: REDUCE201809

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No