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

July 14, 2021 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

Study Type

Observational

Enrollment (Anticipated)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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