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Adjuvant Chemotherapy in High Risk Stage II Colon Cancer

Primary Purpose

Stage II Colon Cancer, Adjuvant Chemotherapy

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
FOLFOX/XELOX/Capecitabine
Sponsored by
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage II Colon Cancer focused on measuring Stage II colon cancer, Adjuvant Chemotherapy, High-Risk factors, High-Immunoscore®

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 18-75 years old
  2. Pathologically confirmed adenocarcinoma of the colon
  3. Complete resection of the primary tumor without gross or microscopic evidence of residual disease
  4. Histologically proven stage II: T3-T4 N0
  5. At least one of the following factors:T4 staging,Number of examined lymph nodes < 12,poor differentiation (except MSI-H),LVI or PNI,tumor perforation or occlusion
  6. Treatment within 7 weeks following surgery
  7. ECOG PS 0-1
  8. No prior chemo, immuno or radiotherapy
  9. Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study.

Exclusion criteria

  1. Have a birth plan during the clinical trial;
  2. Severe cardiovascular diseases such as cerebrovascular accidents occurring within 6 months, myocardial infarction, hypertension that cannot be controlled after drug intervention, unstable angina pectoris, heart failure (NYHA 2-4), and arrhythmia requiring drugs Intervention;
  3. Dementia, mental state changes or any mental illness that may interfere with understanding or making informed consent or completing a questionnaire;
  4. Subjects with ≥1 peripheral neuropathy according to CTCAE V version 4.03;
  5. Allergy or hypersensitivity history of the drug or drug ingredient used in this test;
  6. Excluding other malignant tumors, cured basal cell carcinoma of the skin or squamous cell carcinoma of the skin or any other part of the carcinoma in situ;
  7. Have received any other test drug treatment or participated in another interventional clinical trial within 30 days of the screening period;
  8. The investigator believes that it is not suitable for inclusion.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    observation group

    adjuvant chemotherapy group

    Arm Description

    Patients enrolled in the observation group will not receive any chemotherapy drugs

    Patients enrolled in the chemotherapy group will receive postoperative chemotherapy (investigator's choice) for 3 months or 6 months.

    Outcomes

    Primary Outcome Measures

    Disease Free Survival (DFS)
    To evaluate the noninferiority of observation as compared to standard of care adjuvant chemotherapy (investigator's choice) in patients with high-risk stage II CC and High-Immunoscore® in terms of disease free survival (DFS).

    Secondary Outcome Measures

    Time to Recurrence (TTR)
    To evaluate the noninferiority of observation as compared to standard of care adjuvant chemotherapy (investigator's choice) in patients with high-risk stage II CC and High-Immunoscore® in terms of Time To Recurrence (TTR)
    Overall Survival (OS)
    To evaluate the noninferiority of observation as compared to standard of care adjuvant chemotherapy (investigator's choice) in patients with high-risk stage II CC and High-Immunoscore® in terms of overall survival (OS)

    Full Information

    First Posted
    March 5, 2020
    Last Updated
    April 6, 2020
    Sponsor
    Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04303429
    Brief Title
    Adjuvant Chemotherapy in High Risk Stage II Colon Cancer
    Official Title
    Adjuvant Chemotherapy Versus Observation in Stage II Colon Cancer Patients With High-Risk Factors and High-Immunoscore®
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2020 (Anticipated)
    Primary Completion Date
    January 2022 (Anticipated)
    Study Completion Date
    January 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Benefit of adjuvant chemotherapy after curative surgery for stage II Colon Cancer is still debated. Several high-risk features may help to stratify stage II cancer patients into groups that will truly benefit from adjuvant chemotherapy. However, those factors are rather subjective, and no specific trial has been designed to answer the high-risk stage II colon cancer question directly. Immunoscore® Colon, an in vitro diagnostic test, which quantifies the density of CD3+ and CD8+ T lymphocyte populations in the center the tumor (CT) and its invasive margin (IM) using immunohistochemistry and automated image analysis. Immunoscore® has been extensively validated as a prognostic biomarker in early stage CC patients. This unique diagnostic assay measuring host immune response at the tumor site may inform the decision to administer adjuvant chemotherapy in resected Stage II and III CC patients. This randomized trial is studying how observation compares to adjuvant chemotherapy (investigator's choice) in stage II colon cancer patients with high-risk features and High-Immunoscore®. The trial would represent a unique opportunity to classify stage II CC patients based on their tumor microenvironment with the aim to provide efficient patient stratification to improve clinical care.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stage II Colon Cancer, Adjuvant Chemotherapy
    Keywords
    Stage II colon cancer, Adjuvant Chemotherapy, High-Risk factors, High-Immunoscore®

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    962 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    observation group
    Arm Type
    No Intervention
    Arm Description
    Patients enrolled in the observation group will not receive any chemotherapy drugs
    Arm Title
    adjuvant chemotherapy group
    Arm Type
    Experimental
    Arm Description
    Patients enrolled in the chemotherapy group will receive postoperative chemotherapy (investigator's choice) for 3 months or 6 months.
    Intervention Type
    Drug
    Intervention Name(s)
    FOLFOX/XELOX/Capecitabine
    Intervention Description
    Patients enrolled in the chemotherapy group will receive postoperative chemotherapy (investigator's choice) for 3 months or 6 months.
    Primary Outcome Measure Information:
    Title
    Disease Free Survival (DFS)
    Description
    To evaluate the noninferiority of observation as compared to standard of care adjuvant chemotherapy (investigator's choice) in patients with high-risk stage II CC and High-Immunoscore® in terms of disease free survival (DFS).
    Time Frame
    3 years
    Secondary Outcome Measure Information:
    Title
    Time to Recurrence (TTR)
    Description
    To evaluate the noninferiority of observation as compared to standard of care adjuvant chemotherapy (investigator's choice) in patients with high-risk stage II CC and High-Immunoscore® in terms of Time To Recurrence (TTR)
    Time Frame
    From date of enrollment until the date of recurrence,assessed 1year,3years and 5years after therapy
    Title
    Overall Survival (OS)
    Description
    To evaluate the noninferiority of observation as compared to standard of care adjuvant chemotherapy (investigator's choice) in patients with high-risk stage II CC and High-Immunoscore® in terms of overall survival (OS)
    Time Frame
    From date of enrollment until the date of death,assessed 1year,3years and 5years after therapy
    Other Pre-specified Outcome Measures:
    Title
    Cost Utility Analysis
    Description
    An cost utility analysis at the country level will be conducted alongside the clinical evaluation (exploratory)
    Time Frame
    through study completion,an average of 3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18-75 years old Pathologically confirmed adenocarcinoma of the colon Complete resection of the primary tumor without gross or microscopic evidence of residual disease Histologically proven stage II: T3-T4 N0 At least one of the following factors:T4 staging,Number of examined lymph nodes < 12,poor differentiation (except MSI-H),LVI or PNI,tumor perforation or occlusion Treatment within 7 weeks following surgery ECOG PS 0-1 No prior chemo, immuno or radiotherapy Patients must read, agree to, and sign a statement of Informed Consent prior to participation in this study. Exclusion criteria Have a birth plan during the clinical trial; Severe cardiovascular diseases such as cerebrovascular accidents occurring within 6 months, myocardial infarction, hypertension that cannot be controlled after drug intervention, unstable angina pectoris, heart failure (NYHA 2-4), and arrhythmia requiring drugs Intervention; Dementia, mental state changes or any mental illness that may interfere with understanding or making informed consent or completing a questionnaire; Subjects with ≥1 peripheral neuropathy according to CTCAE V version 4.03; Allergy or hypersensitivity history of the drug or drug ingredient used in this test; Excluding other malignant tumors, cured basal cell carcinoma of the skin or squamous cell carcinoma of the skin or any other part of the carcinoma in situ; Have received any other test drug treatment or participated in another interventional clinical trial within 30 days of the screening period; The investigator believes that it is not suitable for inclusion.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    qi li, MD,PhD
    Phone
    +8613818207333
    Email
    Leeqi2001@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Haiyan Zhang, MD
    Phone
    +8613611956117
    Email
    Zhymmx@sina.com

    12. IPD Sharing Statement

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    Adjuvant Chemotherapy in High Risk Stage II Colon Cancer

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