Zinc Supplement in Regorafenib Treated mCRC Patient

Phase 2

Completed

• Conditions: Colorectal Cancer Metastatic
• Interventions: Drug: Regorafenib; Dietary Supplement: Zinc gluconate supplement

• Registration Number: NCT03898102
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Study Start: 2016-03
• Status Verified: 2019-03
• Primary Completion: 2019-03
• Study Completion: 2019-03
• Study First Submitted: 2019-03-27
• Study First Submitted QC: 2019-03-29
• Last Update Submitted: 2019-03-29
• Study First Posted: 2019-04-01
• Last Update Posted: 2019-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regorafenib treatment only	Regorafenib	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.
Regorafenib treatment with Zn supplement	Regorafenib	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.
Regorafenib treatment with Zn supplement	Zinc gluconate supplement	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.

Primary Outcome Measures

Name	Time	Method
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	8 weeks	Percentages

Secondary Outcome Measures

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