Colorectal Cancer Metastatic
Conditions
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.
Interventions
DRUGRegorafenib
regorafenib plus zinc gluconate
DIETARY_SUPPLEMENTZinc gluconate supplement
Zinc gluconate supplement
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of zinc deficiency before and after regorafenib treatment at weeks 8 | 8 weeks | Percentages |
| Percentage of regorafenib dose reduction | Through study completion, estimated 2 years | Percentages |
| Progression Free Survival (PFS) | Through study completion, estimated 2 years | months |
| Percentage of zinc deficiency before and after regorafenib treatment at weeks 4 | 4 weeks | Percentages |
| Disease control rate (DCR) | 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 |
| Objective tumor response rate (ORR) | Through study completion, estimated 2 years | rate |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with clinically important change in vital sign results from baseline, as assessed by respiratory rate | Through study completion, estimated 2 years | Percentage |
| Percentage of patients with clinically important change in vital sign results from baseline, as assessed by body temperature | Through study completion, estimated 2 years | Percentage |
| Percentage of patients with clinically significant finding in physical examination results, as assessed by general appearance | Through study completion, estimated 2 years | Percentage |
| Percentage of patients with significant changes from baseline in clinical laboratory test results, assessed by biochemistry panel | Through study completion, estimated 2 years | Percentage |
| Percentage of patients with adverse events (graded by NCI-CTCAE v4.03) | Through study completion, estimated 2 years | Percentage |
| Percentage of patients with significant changes from baseline in clinical laboratory test results, assessed by hematology panel | Through study completion, estimated 2 years | Percentage |
| Percentage of patients with clinically significant finding in physical examination results, as assessed by HEENT (head, eyes, ears, nose, and throat) | Through study completion, estimated 2 years | Percentage |
| Percentage of patients with clinically significant finding in physical examination results, as assessed by mouth | Through study completion, estimated 2 years | Percentage |
| Percentage of patients with clinically significant finding in physical examination results, as assessed by skin | Through study completion, estimated 2 years | Percentage |
| Percentage of patients with clinically significant finding in physical examination results, as assessed by neck (thyroid gland included) | Through study completion, estimated 2 years | Percentage |
| Percentage of patients with clinically significant finding in physical examination results, as assessed by lymph nodes | Through study completion, estimated 2 years | Percentage |
| Percentage of patients with clinically important change in vital sign results from baseline, as assessed by systolic pressure | Through study completion, estimated 2 years | Percentage |
| Percentage of patients with clinically important change in vital sign results from baseline, as assessed by diastolic blood pressure | Through study completion, estimated 2 years | Percentage |
| Percentage of patients with clinically important change in vital sign results from baseline, as assessed by pulse rate | Through study completion, estimated 2 years | Percentage |
Outcome results
None listed