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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03958435
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : July 15, 2021
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Description
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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
Stage II Colon Cancer Stage III Colon Cancer Adjuvant Therapy

Study Design
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Study Type : Observational
Estimated 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 : November 9, 2018
Estimated Primary Completion Date : October 15, 2022
Estimated Study Completion Date : December 15, 2023
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  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 [ 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.)
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958435


Contacts
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Contact: Ying Yuan, Ph.D&MD +86-571-87784795 yuanying1999@zju.edu.cn

Locations
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China, Jiangsu
Jiangsu Province People Hospital Recruiting
Nanjing, Jiangsu, China
Contact: Yanhong Gu, MD         
China, Shanghai
Changhai Hospital of Shanghai Recruiting
Shanghai, Shanghai, China
Contact: Wei Zhang, MD         
China, Zhejinag
SAHZU Recruiting
Hangzhou, Zhejinag, China, 310009
Contact: Ying Yuan, Ph.D & MD       yuanying1999@zju.edu.cn   
Contact: Ying Yuan       yuanying1999@zju.edu.cn   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
More Information
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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT03958435    
Other Study ID Numbers: REDUCE201809
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: July 15, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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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:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases