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Completed

NCT Number: NCT03898102

Zinc Supplement in Regorafenib Treated mCRC Patient

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

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Key information

Conditions

Colorectal Cancer Metastatic

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

regorafenib

Drug

regorafenib plus zinc gluconate

Zinc gluconate supplement

Dietary Supplement

Zinc gluconate supplement

Primary outcomes

  1. 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

Secondary outcomes

  1. Percentage of zinc deficiency before and after regorafenib treatment at weeks 4

    Time frame: 4 weeks

    Percentages

  2. Percentage of zinc deficiency before and after regorafenib treatment at weeks 8

    Time frame: 8 weeks

    Percentages

  3. Percentage of regorafenib dose reduction

    Time frame: Through study completion, estimated 2 years

    Percentages

  4. Progression Free Survival (PFS)

    Time frame: Through study completion, estimated 2 years

    months

  5. Objective tumor response rate (ORR)

    Time frame: Through study completion, estimated 2 years

    rate

  6. Disease control rate (DCR)

    Time frame: Through study completion, estimated 2 years

    rate

  7. Overall survival (OS)

    Time frame: Through study completion, estimated 2 years

    months

  8. Duration of treatment of regorafenib (DoT)

    Time frame: through study completion, estimated 2 years

    months

Other outcomes

  1. 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

  2. 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

  3. Percentage of patients with clinically significant finding in physical examination results, as assessed by mouth

    Time frame: Through study completion, estimated 2 years

    Percentage

  4. Percentage of patients with clinically significant finding in physical examination results, as assessed by skin

    Time frame: Through study completion, estimated 2 years

    Percentage

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. Percentage of patients with adverse events (graded by NCI-CTCAE v4.03)

    Time frame: Through study completion, estimated 2 years

    Percentage

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Acronym: ZnCORRECT

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 1, 2019
Registry last updated
Apr 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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