Zinc Supplement in Regorafenib Treated mCRC Patient

Study Overview
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Brief Summary
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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
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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.

Official Title
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Zinc Supplement in Metastatic Colorectal Cancer Patients Receiving Regorafenib: Phase II Prospective Randomized Trial

Conditions
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Colorectal Cancer Metastatic

Intervention / Treatment
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* Drug: Regorafenib
* Dietary Supplement: Zinc gluconate supplement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regorafenib treatment with Zn supplement<br>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. | Drug: Regorafenib<br>* regorafenib plus zinc gluconate<br>Dietary Supplement: Zinc gluconate supplement<br>* Zinc gluconate supplement<br>|
| Active Comparator: Regorafenib treatment only<br>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. | Drug: Regorafenib<br>* regorafenib plus zinc gluconate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of zinc deficiency before and after regorafenib treatment at weeks 4 | Percentages | 4 weeks | 
| Percentage of zinc deficiency before and after regorafenib treatment at weeks 8 | Percentages | 8 weeks | 
| Percentage of regorafenib dose reduction | Percentages | Through study completion, estimated 2 years | 
| Progression Free Survival (PFS) | months | Through study completion, estimated 2 years | 
| Objective tumor response rate (ORR) | rate | Through study completion, estimated 2 years | 
| Disease control rate (DCR) | rate | Through study completion, estimated 2 years | 
| Overall survival (OS) | months | Through study completion, estimated 2 years | 
| Duration of treatment of regorafenib (DoT) | months | through study completion, estimated 2 years |