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Maintenance Chemotherapy for Metastatic Colorectal Carcinoma and Biological Marker

Primary Purpose

Metastatic Colorectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Capecitabine
placebo
Sponsored by
Beijing Chao Yang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer

Eligibility Criteria

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

Inclusion Criteria:

- Age between 18 and 75 years Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 histologically confirmed colorectal cancer with inoperable locally advanced or recurrent and/or metastatic disease Life expectancy of at least 3 months Intact organ function, including complete blood counts (CBC) showing normal values or any toxicity limited to grade 1 and blood chemistry (SMA) showing liver and renal functions < 1.5 upper normal limit (UNL).

Patients who achieved objective response or stable disease after 16-24 weeks first line chemotherapy Signed informed consent

Exclusion Criteria:

- Known hypersensitivity to capecitabine Concurrent any other cancer (except BCC or squamous cell carcinoma of skin). Inability to adhere to monthly visits to the oncology unit for evaluation. Presence of brain metastases. Previous radiotherapy to the only site of measurable disease. Evidence of severe or uncontrolled systemic disease No previous chemotherapy for metastatic disease Positive serum pregnancy test in women of childbearing potential unresolved bowel obstruction or malabsorption syndrome

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Experimental

    Arm Label

    Placebo

    Capecitabine

    Arm Description

    Placebo 1250mg/m2 tablet by mouth every 12 hours for 14 days

    Capecitabine 1250mg/m2 tablet by mouth every 12 hours for 14 days

    Outcomes

    Primary Outcome Measures

    DDC:Duration of Disease Control
    progression-free survival of first-line chemotherapy with second-line chemotherapy

    Secondary Outcome Measures

    OS:Overall Survival
    measured from the initiation of chemotherapy to the date of the last follow-up or death
    DCR:Disease Control Rate
    This is defined as the occurrence of either a confirmed complete (CR),a partial response(PR)or stable disease(SD) as determined by the RECIST criteria from confirmed radiographic evaluations of target and non-target lesions.

    Full Information

    First Posted
    January 21, 2014
    Last Updated
    January 23, 2014
    Sponsor
    Beijing Chao Yang Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02043821
    Brief Title
    Maintenance Chemotherapy for Metastatic Colorectal Carcinoma and Biological Marker
    Official Title
    Maintenance Chemotherapy for Metastatic Colorectal Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    January 2016 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Beijing Chao Yang Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Colorectal cancer patients with metastases (mCRC) at response under first-line chemotherapy are candidates for an convenient maintenance treatment.
    Detailed Description
    Colorectal cancer is one of the most common malignant tumors, with the morbidity of approximate 100 million cases per year. About 40% of patients present with metastatic (stage IV) colorectal cancer at the time of diagnosis, and about 25% of patients with local lesion will ultimately develop metastatic disease.Therefore, our study is designed to investigate that colorectal cancer patients with metastases (mCRC) at response under first-line chemotherapy are candidates for an convenient maintenance treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metastatic Colorectal Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Other
    Arm Description
    Placebo 1250mg/m2 tablet by mouth every 12 hours for 14 days
    Arm Title
    Capecitabine
    Arm Type
    Experimental
    Arm Description
    Capecitabine 1250mg/m2 tablet by mouth every 12 hours for 14 days
    Intervention Type
    Drug
    Intervention Name(s)
    Capecitabine
    Intervention Description
    14days
    Intervention Type
    Other
    Intervention Name(s)
    placebo
    Intervention Description
    14 days
    Primary Outcome Measure Information:
    Title
    DDC:Duration of Disease Control
    Description
    progression-free survival of first-line chemotherapy with second-line chemotherapy
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    OS:Overall Survival
    Description
    measured from the initiation of chemotherapy to the date of the last follow-up or death
    Time Frame
    2 years
    Title
    DCR:Disease Control Rate
    Description
    This is defined as the occurrence of either a confirmed complete (CR),a partial response(PR)or stable disease(SD) as determined by the RECIST criteria from confirmed radiographic evaluations of target and non-target lesions.
    Time Frame
    2 years
    Other Pre-specified Outcome Measures:
    Title
    Safety
    Description
    Adverse events and laboratory tests graded according to the NCI-CTC AE Version 4.
    Time Frame
    2 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 between 18 and 75 years Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 histologically confirmed colorectal cancer with inoperable locally advanced or recurrent and/or metastatic disease Life expectancy of at least 3 months Intact organ function, including complete blood counts (CBC) showing normal values or any toxicity limited to grade 1 and blood chemistry (SMA) showing liver and renal functions < 1.5 upper normal limit (UNL). Patients who achieved objective response or stable disease after 16-24 weeks first line chemotherapy Signed informed consent Exclusion Criteria: - Known hypersensitivity to capecitabine Concurrent any other cancer (except BCC or squamous cell carcinoma of skin). Inability to adhere to monthly visits to the oncology unit for evaluation. Presence of brain metastases. Previous radiotherapy to the only site of measurable disease. Evidence of severe or uncontrolled systemic disease No previous chemotherapy for metastatic disease Positive serum pregnancy test in women of childbearing potential unresolved bowel obstruction or malabsorption syndrome
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dong Yan, PhD
    Phone
    13621308215
    Email
    yd15yt88@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Guangyu An, PhD
    Organizational Affiliation
    Beijing Chao Yang Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Maintenance Chemotherapy for Metastatic Colorectal Carcinoma and Biological Marker

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