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

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03958435
Collaborator
(none)
20,000
Enrollment
3
Locations
61.2
Anticipated Duration (Months)
6666.7
Patients Per Site
109
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20000 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Real-world Retrospective Data Analysis of Adjuvant Therapy for Patients With Stage II-III Colon Cancer After Radical Surgery
    Actual Study Start Date :
    Nov 9, 2018
    Anticipated Primary Completion Date :
    Oct 15, 2022
    Anticipated Study Completion Date :
    Dec 15, 2023

    Outcome Measures

    Primary Outcome Measures

    1. 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

    2. 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

    3. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jiangsu Province People Hospital Nanjing Jiangsu China
    2 Changhai Hospital of Shanghai Shanghai Shanghai China
    3 SAHZU Hangzhou Zhejinag China 310009

    Sponsors and Collaborators

    • Second Affiliated Hospital, School of Medicine, Zhejiang University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    ClinicalTrials.gov Identifier:
    NCT03958435
    Other Study ID Numbers:
    • REDUCE201809
    First Posted:
    May 22, 2019
    Last Update Posted:
    Jul 15, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University
    Current status
    Chemotherapy regimen
    Chemotherapy time
    Efficacy
    Safety
    Adjuvant therapy
    Stage II-III colon cancer
    RWS(Real World Study)
    Additional relevant MeSH terms:
    Colonic Neoplasms

    Study Results

    No Results Posted as of Jul 15, 2021