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Maintenance Treatment With Capecitabine Metronomic Chemotherapy and Chinese Traditional Medicine in Metastatic Colorectal Cancer

Primary Purpose

Metastatic Colorectal Cancer

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Metronimic chemotherapy plus Chinese Traditional Medicine
Metronimic chemotherapy
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Metastatic Colorectal Cancer, Maintenance Treatment, Chinese Traditional Medicine, Clinical Trial, efficacy, safety

Eligibility Criteria

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

Inclusion Criteria:

  1. unresectable metastatic colorectal cancer with pathological confirmation.
  2. patients have accepted 18-24 weeks first-line chemotherapy and disease evaluation is SD, PR or CR.

Exclusion Criteria:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    Metronomic chemotherapy

    Metronimic chemotherapy plus Chinese Traditional Medicine

    Arm Description

    Metronomic Chemotherapy for maintenance treatment with Capecitabine 300mg/m2 twice a day, everyday.

    Metronomic Chemotherapy for maintenance treatment with Capecitabine 300mg/m2 twice a day, everyday. Chinese Traditional Medicine

    Outcomes

    Primary Outcome Measures

    Progression-free survival
    from randomising to progression, death, unacceptable AE

    Secondary Outcome Measures

    Full Information

    First Posted
    October 10, 2015
    Last Updated
    October 13, 2015
    Sponsor
    Ruijin Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02575378
    Brief Title
    Maintenance Treatment With Capecitabine Metronomic Chemotherapy and Chinese Traditional Medicine in Metastatic Colorectal Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    June 2018 (Anticipated)
    Study Completion Date
    December 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ruijin Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The optimum regimen of maintenance treatment after first-line chemotherapy in patients with metastatic colorectal cancer （mCRC） is unknown. This study was designed to determine the efficacy and safety of maintenance treatment with capecitabine metronomic chemotherapy plus Chinese Traditional Medicine. In this Prospective, open-label, randomised controlled trial, the investigators will recruit 159 mCRC patients who have finished 18 to 24 weeks first-line chemotherapy and disease evaluation is SD, PR or CR. The patients will then accept Chinese traditional diagnosis and be randomised into two group, capecitabine metronomic chemotherapy only as control group and the metronomic chemotherapy plus Chinese Traditional Medicine as experimental group. This treatment regimen will be continued until progression, death, or an unacceptable adverse event. The primary endpoint is progression-free survival (PFS). Secondary endpoints are overall survival (OS), quality of life (QOL) and toxic effects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metastatic Colorectal Cancer
    Keywords
    Metastatic Colorectal Cancer, Maintenance Treatment, Chinese Traditional Medicine, Clinical Trial, efficacy, safety

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    159 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Metronomic chemotherapy
    Arm Type
    Other
    Arm Description
    Metronomic Chemotherapy for maintenance treatment with Capecitabine 300mg/m2 twice a day, everyday.
    Arm Title
    Metronimic chemotherapy plus Chinese Traditional Medicine
    Arm Type
    Experimental
    Arm Description
    Metronomic Chemotherapy for maintenance treatment with Capecitabine 300mg/m2 twice a day, everyday. Chinese Traditional Medicine
    Intervention Type
    Drug
    Intervention Name(s)
    Metronimic chemotherapy plus Chinese Traditional Medicine
    Intervention Description
    Capecitabine 300mg/m2, twice a day, everyday plus Chinese Traditional Medicine
    Intervention Type
    Drug
    Intervention Name(s)
    Metronimic chemotherapy
    Intervention Description
    Capecitabine 300mg/m2, twice a day, everyday
    Primary Outcome Measure Information:
    Title
    Progression-free survival
    Description
    from randomising to progression, death, unacceptable AE
    Time Frame
    six months

    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: unresectable metastatic colorectal cancer with pathological confirmation. patients have accepted 18-24 weeks first-line chemotherapy and disease evaluation is SD, PR or CR. Exclusion Criteria: -

    12. IPD Sharing Statement

    Learn more about this trial

    Maintenance Treatment With Capecitabine Metronomic Chemotherapy and Chinese Traditional Medicine in Metastatic Colorectal Cancer

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