Colorectal Cancer MetastaticPhase 2ZnCORRECTNCT03898102
Zinc Supplement in Regorafenib Treated mCRC Patient
A Phase 2 study testing Regorafenib and Zinc gluconate supplement in people with Colorectal Cancer Metastatic, run by Chang Gung Memorial Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- Regorafenib and Zinc gluconate supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Mar 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- Regorafenib, Zinc gluconate supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegorafenibDrug
regorafenib plus zinc gluconate
Zinc gluconate supplementDietary supplement
Zinc gluconate supplement
| Study group | Role | What they receive |
|---|---|---|
| Regorafenib treatment with Zn supplement | Experimental | 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. Receives: Drug: Regorafenib; Dietary Supplement: Zinc gluconate supplement |
| Regorafenib treatment only | Active comparator | 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. Receives: Drug: Regorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Secondary outcomes (8)
Percentage of zinc deficiency before and after regorafenib treatment at weeks 4
Percentages
Measured: 4 weeks
Percentage of zinc deficiency before and after regorafenib treatment at weeks 8
Percentages
Measured: 8 weeks
Percentage of regorafenib dose reduction
Percentages
Measured: Through study completion, estimated 2 years
Progression Free Survival (PFS)
months
Measured: Through study completion, estimated 2 years
Objective tumor response rate (ORR)
rate
Measured: Through study completion, estimated 2 years
Disease control rate (DCR)
rate
Measured: Through study completion, estimated 2 years
Overall survival (OS)
months
Measured: Through study completion, estimated 2 years
Duration of treatment of regorafenib (DoT)
months
Measured: through study completion, estimated 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study startMar 2016
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeh Chun-Nan, Chang Gung Memorial Hospital
- Investigators
- Chun-Nan Yeh, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03898102
- Sponsor's protocol ID
- 1901090003
- Acronym
- ZnCORRECT
- Status last verified
- Mar 2019
- First submitted
- 27 Mar 2019
- Last updated
- 1 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huang WK, Hsu HC, Yang TS, Lu CW, Pan YR, Wu CE, Chung WH, Hung SI, Yeh CN. Zinc supplementation decreased incidence of grade >/=2 hand-foot skin reaction induced by regorafenib: A phase II randomized clinical trial. Eur J Cancer. 2023 Dec;195:113286. doi: 10.1016/j.ejca.2023.113286. Epub 2023 Nov 13.
PubMed 37968194
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zinc Supplement in Metastatic Colorectal Cancer Patients Receiving Regorafenib: Phase II Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT03898102
- Acronym / sponsor ID
- ZnCORRECT / 1901090003
- Conditions
- Colorectal Cancer Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 1 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regorafenib treatment with Zn supplement | Experimental | Drug: Regorafenib, Dietary Supplement: Zinc gluconate supplementPatients 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 only | Active comparator | Drug: RegorafenibPatients 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regorafenibregorafenib plus zinc gluconate | Drug | Regorafenib treatment only, Regorafenib treatment with Zn supplement |
| Zinc gluconate supplementZinc gluconate supplement | Dietary supplement | Regorafenib treatment with Zn supplement |
Primary outcome
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 secondary outcomes
Percentage of zinc deficiency before and after regorafenib treatment at weeks 4
Time frame: 4 weeks
Percentage of zinc deficiency before and after regorafenib treatment at weeks 8
Time frame: 8 weeks
Percentage of regorafenib dose reduction
Time frame: Through study completion, estimated 2 years
Progression Free Survival (PFS)
Time frame: Through study completion, estimated 2 years
Objective tumor response rate (ORR)
Time frame: Through study completion, estimated 2 years
Disease control rate (DCR)
Time frame: Through study completion, estimated 2 years
Overall survival (OS)
Time frame: Through study completion, estimated 2 years
Duration of treatment of regorafenib (DoT)
Time frame: through study completion, estimated 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2019.
- Derived from this study: PubMed 37968194Huang WK, Hsu HC, Yang TS, Lu CW, Pan YR, Wu CE, Chung WH, Hung SI, Yeh CN. Zinc supplementation decreased incidence of grade >/=2 hand-foot skin reaction induced by regorafenib: A phase II randomized clinical trial. Eur J Cancer. 2023 Dec;195:113286. doi: 10.1016/j.ejca.2023.113286. Epub 2023 Nov 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun-Nan Yeh, MD principal investigator
Chang Gung Memorial Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Regorafenib and Zinc gluconate supplement in people with Colorectal Cancer Metastatic, run by Chang Gung Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03898102, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2019.