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
About this trial
This is an interventional treatment trial for Colorectal Cancer Metastatic
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
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
NCT ID
NCT03898102
First Posted
March 27, 2019
Last Updated
March 29, 2019
Sponsor
Chang Gung Memorial Hospital
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
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