search
Back to results

Zinc Supplement in Regorafenib Treated mCRC Patient (ZnCORRECT)

Primary Purpose

Colorectal Cancer Metastatic

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Regorafenib
Zinc gluconate supplement
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer Metastatic

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients diagnosed with mCRC who have been previously treated with, or are not considered candidates for, other locally approved standard treatment(s) and for whom the decision has been made per investigator's routine treatment practice to prescribe regorafenib
  • Ability to understand and willingness to sign written Informed Consent Form (ICF)

Exclusion Criteria:

  • Patients participating in an investigational program with interventions outside of routine clinical practice
  • Patients with baseline Zinc level above 120 ug/dL
  • Patients with known allergy to Zinc supplementation
  • Pregnancy
  • Patients who are unsuitable for study participation, based on investigator's discretion

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Regorafenib treatment with Zn supplement

    Regorafenib treatment only

    Arm Description

    Patients enrolled in this arm received regorafenib with zinc supplementation to examine if zinc supplementation can decrease the incidence of grade 2 or higher HFSR.

    Patients enrolled in this arm received regorafenib without zinc supplementation, which is the standard treatment of patients of metastatic colorectal cancer who failed previous standard therapy.

    Outcomes

    Primary Outcome Measures

    Difference in grade 2 or worse HFSR incidence within the first 8 weeks of regorafenib treatment between mCRC patients who receive regorafenib treatment with or without zinc supplementation
    Percentages

    Secondary Outcome Measures

    Percentage of zinc deficiency before and after regorafenib treatment at weeks 4
    Percentages
    Percentage of zinc deficiency before and after regorafenib treatment at weeks 8
    Percentages
    Percentage of regorafenib dose reduction
    Percentages
    Progression Free Survival (PFS)
    months
    Objective tumor response rate (ORR)
    rate
    Disease control rate (DCR)
    rate
    Overall survival (OS)
    months
    Duration of treatment of regorafenib (DoT)
    months

    Full Information

    First Posted
    March 27, 2019
    Last Updated
    March 29, 2019
    Sponsor
    Chang Gung Memorial Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03898102
    Brief Title
    Zinc Supplement in Regorafenib Treated mCRC Patient
    Acronym
    ZnCORRECT
    Official Title
    Zinc Supplement in Metastatic Colorectal Cancer Patients Receiving Regorafenib: Phase II Prospective Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2016 (Actual)
    Primary Completion Date
    March 2019 (Actual)
    Study Completion Date
    March 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chang Gung Memorial Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Phase II randomized trial to investigate whether supplementation of zinc decreases the incidence of HFSR that occurs after treatment of tyrosine kinase inhibitor, regorafenib.
    Detailed Description
    This study is aimed to investigate the effect of zinc supplementation on improving regorafenib treatment safety and efficacy in patients with metastatic colorectal cancer (mCRC). The difference in grade 2 or worse hand-foot skin reaction (HFSR) incidence within the first 8 weeks of regorafenib treatment between two arms will be examined as the primary objective.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    65 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Regorafenib treatment with Zn supplement
    Arm Type
    Experimental
    Arm Description
    Patients enrolled in this arm received regorafenib with zinc supplementation to examine if zinc supplementation can decrease the incidence of grade 2 or higher HFSR.
    Arm Title
    Regorafenib treatment only
    Arm Type
    Active Comparator
    Arm Description
    Patients enrolled in this arm received regorafenib without zinc supplementation, which is the standard treatment of patients of metastatic colorectal cancer who failed previous standard therapy.
    Intervention Type
    Drug
    Intervention Name(s)
    Regorafenib
    Intervention Description
    regorafenib plus zinc gluconate
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Zinc gluconate supplement
    Intervention Description
    Zinc gluconate supplement
    Primary Outcome Measure Information:
    Title
    Difference in grade 2 or worse HFSR incidence within the first 8 weeks of regorafenib treatment between mCRC patients who receive regorafenib treatment with or without zinc supplementation
    Description
    Percentages
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Percentage of zinc deficiency before and after regorafenib treatment at weeks 4
    Description
    Percentages
    Time Frame
    4 weeks
    Title
    Percentage of zinc deficiency before and after regorafenib treatment at weeks 8
    Description
    Percentages
    Time Frame
    8 weeks
    Title
    Percentage of regorafenib dose reduction
    Description
    Percentages
    Time Frame
    Through study completion, estimated 2 years
    Title
    Progression Free Survival (PFS)
    Description
    months
    Time Frame
    Through study completion, estimated 2 years
    Title
    Objective tumor response rate (ORR)
    Description
    rate
    Time Frame
    Through study completion, estimated 2 years
    Title
    Disease control rate (DCR)
    Description
    rate
    Time Frame
    Through study completion, estimated 2 years
    Title
    Overall survival (OS)
    Description
    months
    Time Frame
    Through study completion, estimated 2 years
    Title
    Duration of treatment of regorafenib (DoT)
    Description
    months
    Time Frame
    through study completion, estimated 2 years
    Other Pre-specified Outcome Measures:
    Title
    Percentage of patients with clinically significant finding in physical examination results, as assessed by general appearance
    Description
    Percentage
    Time Frame
    Through study completion, estimated 2 years
    Title
    Percentage of patients with clinically significant finding in physical examination results, as assessed by HEENT (head, eyes, ears, nose, and throat)
    Description
    Percentage
    Time Frame
    Through study completion, estimated 2 years
    Title
    Percentage of patients with clinically significant finding in physical examination results, as assessed by mouth
    Description
    Percentage
    Time Frame
    Through study completion, estimated 2 years
    Title
    Percentage of patients with clinically significant finding in physical examination results, as assessed by skin
    Description
    Percentage
    Time Frame
    Through study completion, estimated 2 years
    Title
    Percentage of patients with clinically significant finding in physical examination results, as assessed by neck (thyroid gland included)
    Description
    Percentage
    Time Frame
    Through study completion, estimated 2 years
    Title
    Percentage of patients with clinically significant finding in physical examination results, as assessed by lymph nodes
    Description
    Percentage
    Time Frame
    Through study completion, estimated 2 years
    Title
    Percentage of patients with clinically important change in vital sign results from baseline, as assessed by systolic pressure
    Description
    Percentage
    Time Frame
    Through study completion, estimated 2 years
    Title
    Percentage of patients with clinically important change in vital sign results from baseline, as assessed by diastolic blood pressure
    Description
    Percentage
    Time Frame
    Through study completion, estimated 2 years
    Title
    Percentage of patients with clinically important change in vital sign results from baseline, as assessed by pulse rate
    Description
    Percentage
    Time Frame
    Through study completion, estimated 2 years
    Title
    Percentage of patients with clinically important change in vital sign results from baseline, as assessed by respiratory rate
    Description
    Percentage
    Time Frame
    Through study completion, estimated 2 years
    Title
    Percentage of patients with clinically important change in vital sign results from baseline, as assessed by body temperature
    Description
    Percentage
    Time Frame
    Through study completion, estimated 2 years
    Title
    Percentage of patients with significant changes from baseline in clinical laboratory test results, assessed by hematology panel
    Description
    Percentage
    Time Frame
    Through study completion, estimated 2 years
    Title
    Percentage of patients with significant changes from baseline in clinical laboratory test results, assessed by biochemistry panel
    Description
    Percentage
    Time Frame
    Through study completion, estimated 2 years
    Title
    Percentage of patients with adverse events (graded by NCI-CTCAE v4.03)
    Description
    Percentage
    Time Frame
    Through study completion, estimated 2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients diagnosed with mCRC who have been previously treated with, or are not considered candidates for, other locally approved standard treatment(s) and for whom the decision has been made per investigator's routine treatment practice to prescribe regorafenib Ability to understand and willingness to sign written Informed Consent Form (ICF) Exclusion Criteria: Patients participating in an investigational program with interventions outside of routine clinical practice Patients with baseline Zinc level above 120 ug/dL Patients with known allergy to Zinc supplementation Pregnancy Patients who are unsuitable for study participation, based on investigator's discretion
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chun-Nan Yeh, MD
    Organizational Affiliation
    Chang Gung Memorial Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Zinc Supplement in Regorafenib Treated mCRC Patient

    We'll reach out to this number within 24 hrs