Zinc Supplement in Regorafenib Treated mCRC Patient (ZnCORRECT)

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

Phase II randomized trial to investigate whether supplementation of zinc decreases the incidence of HFSR that occurs after treatment of tyrosine kinase inhibitor, regorafenib.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer Metastatic
• Intervention / Treatment: Drug: Regorafenib; Dietary supplement: Zinc gluconate supplement

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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Regorafenib treatment with Zn 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.	Drug: Regorafenib; regorafenib plus zinc gluconate; Dietary supplement: Zinc gluconate supplement; Zinc gluconate supplement
Active Comparator: Regorafenib treatment only; 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; regorafenib plus zinc gluconate

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with clinically significant finding in physical examination results, as assessed by general appearance	Percentage	Through study completion, estimated 2 years
Percentage of patients with clinically significant finding in physical examination results, as assessed by HEENT (head, eyes, ears, nose, and throat)	Percentage	Through study completion, estimated 2 years
Percentage of patients with clinically significant finding in physical examination results, as assessed by mouth	Percentage	Through study completion, estimated 2 years
Percentage of patients with clinically significant finding in physical examination results, as assessed by skin	Percentage	Through study completion, estimated 2 years
Percentage of patients with clinically significant finding in physical examination results, as assessed by neck (thyroid gland included)	Percentage	Through study completion, estimated 2 years
Percentage of patients with clinically significant finding in physical examination results, as assessed by lymph nodes	Percentage	Through study completion, estimated 2 years
Percentage of patients with clinically important change in vital sign results from baseline, as assessed by systolic pressure	Percentage	Through study completion, estimated 2 years
Percentage of patients with clinically important change in vital sign results from baseline, as assessed by diastolic blood pressure	Percentage	Through study completion, estimated 2 years
Percentage of patients with clinically important change in vital sign results from baseline, as assessed by pulse rate	Percentage	Through study completion, estimated 2 years
Percentage of patients with clinically important change in vital sign results from baseline, as assessed by respiratory rate	Percentage	Through study completion, estimated 2 years
Percentage of patients with clinically important change in vital sign results from baseline, as assessed by body temperature	Percentage	Through study completion, estimated 2 years
Percentage of patients with significant changes from baseline in clinical laboratory test results, assessed by hematology panel	Percentage	Through study completion, estimated 2 years
Percentage of patients with significant changes from baseline in clinical laboratory test results, assessed by biochemistry panel	Percentage	Through study completion, estimated 2 years
Percentage of patients with adverse events (graded by NCI-CTCAE v4.03)	Percentage	Through study completion, estimated 2 years

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Chun-Nan Yeh, MD, Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: March 27, 2019
• First Submitted That Met QC Criteria: March 29, 2019
• First Posted (Actual): April 1, 2019

Study Record Updates

• Last Update Posted (Actual): April 1, 2019
• Last Update Submitted That Met QC Criteria: March 29, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 1901090003

Drug and device information, study documents

• 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