Zinc Supplement in Regorafenib Treated mCRC Patient (ZnCORRECT)

March 29, 2019 updated by: Yeh Chun-Nan, Chang Gung Memorial Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: 8 weeks
Percentages
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of zinc deficiency before and after regorafenib treatment at weeks 4
Time Frame: 4 weeks
Percentages
4 weeks
Percentage of zinc deficiency before and after regorafenib treatment at weeks 8
Time Frame: 8 weeks
Percentages
8 weeks
Percentage of regorafenib dose reduction
Time Frame: Through study completion, estimated 2 years
Percentages
Through study completion, estimated 2 years
Progression Free Survival (PFS)
Time Frame: Through study completion, estimated 2 years
months
Through study completion, estimated 2 years
Objective tumor response rate (ORR)
Time Frame: Through study completion, estimated 2 years
rate
Through study completion, estimated 2 years
Disease control rate (DCR)
Time Frame: Through study completion, estimated 2 years
rate
Through study completion, estimated 2 years
Overall survival (OS)
Time Frame: Through study completion, estimated 2 years
months
Through study completion, estimated 2 years
Duration of treatment of regorafenib (DoT)
Time Frame: through study completion, estimated 2 years
months
through study completion, estimated 2 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of patients with clinically significant finding in physical examination results, as assessed by general appearance
Time Frame: Through study completion, estimated 2 years
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)
Time Frame: Through study completion, estimated 2 years
Percentage
Through study completion, estimated 2 years
Percentage of patients with clinically significant finding in physical examination results, as assessed by mouth
Time Frame: Through study completion, estimated 2 years
Percentage
Through study completion, estimated 2 years
Percentage of patients with clinically significant finding in physical examination results, as assessed by skin
Time Frame: Through study completion, estimated 2 years
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)
Time Frame: Through study completion, estimated 2 years
Percentage
Through study completion, estimated 2 years
Percentage of patients with clinically significant finding in physical examination results, as assessed by lymph nodes
Time Frame: Through study completion, estimated 2 years
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
Time Frame: Through study completion, estimated 2 years
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
Time Frame: Through study completion, estimated 2 years
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
Time Frame: Through study completion, estimated 2 years
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
Time Frame: Through study completion, estimated 2 years
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
Time Frame: Through study completion, estimated 2 years
Percentage
Through study completion, estimated 2 years
Percentage of patients with significant changes from baseline in clinical laboratory test results, assessed by hematology panel
Time Frame: Through study completion, estimated 2 years
Percentage
Through study completion, estimated 2 years
Percentage of patients with significant changes from baseline in clinical laboratory test results, assessed by biochemistry panel
Time Frame: Through study completion, estimated 2 years
Percentage
Through study completion, estimated 2 years
Percentage of patients with adverse events (graded by NCI-CTCAE v4.03)
Time Frame: Through study completion, estimated 2 years
Percentage
Through study completion, estimated 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chun-Nan Yeh, MD, Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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