Metastatic Colorectal CancerNCT03829852
Regorafenib in Taiwan Metastatic Colorectal Cancer (mCRC) Patients
An observational study of Metastatic Colorectal Cancer, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Regorafenib is currently the standard of care for refractory mCRC patients. Pivotal studies of regorafenib have proven the efficacy and safety, with a 28-day cycle (21 days on, 7 days off) and 160 mg dose given once daily. In the clinic, patients often have some complicated condition. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Regorafenib
- How many people
- 716 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Feb 2019to 8 Dec 2020
- Phase
- Observational
- 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
Study population: mCRC patients who received regorafenib treatment in Taipei Veterans General Hospital and Chang Gung Memorial Hospital Linkou, Taiwan
Who may be able to join
- mCRC patients who received at least one dose of regorafenib treatment
Who cannot join
- <=20 y/o
- Patients who did not receive regorafenib treatment will be excluded from the analysis
- Patients with incomplete medical records that are deemed ineligible for analysis by investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigate the Real-life Treatment Outcome of Regorafenib in Treating mCRC Patients
Regorafenib is currently the standard of care for refractory mCRC patients. Pivotal studies of regorafenib have proven the efficacy and safety, with a 28-day cycle (21 days on, 7 days off) and 160 mg dose given once daily.
In the clinic, patients often have some complicated condition. This study aims to perform retrospective medical chart review of mCRC patients who received regorafenib treatment in two medical centers in Taiwan to examine treatment effectiveness in the routine clinical practice setting.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Regorafenib
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegorafenibDrug
Treatment was performed based on physician's discretion
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of regorafenib use in routine clinical practice setting, assessed by overall survival (OS)
months
Measured: through study completion, estimated 2 years
Effectiveness of regorafenib use in routine clinical practice setting, assessed by progression free survival (PFS)
months
Measured: through study completion, estimated 2 years
Effectiveness of regorafenib use in routine clinical practice setting, assessed by time to progression (TTP)
months
Measured: through study completion, estimated 2 years
Effectiveness of regorafenib use in routine clinical practice setting, assessed by tumor response
percentage
Measured: through study completion, estimated 2 years
Secondary outcomes (6)
Safety of regorafenib use in routine clinical practice setting, assessed by incidence of adverse events (AEs)
percentage
Measured: through study completion, estimated 2 years
Safety of regorafenib use in routine clinical practice setting, assessed by initial dose
percentage
Measured: through study completion, estimated 2 years
Safety of regorafenib use in routine clinical practice setting, assessed by dose intensity during the first 2 cycles
percentage
Measured: through study completion, estimated 2 years
Eligibility of subsequent therapies and the outcome, assessed by type of treatment (anti-epithelial growth factor receptor [EGFR], anti-vascular endothelial growth factor [VEGF], and/or chemotherapy agents)
percentage
Measured: through study completion, estimated 2 years
Eligibility of subsequent therapies and the outcome, assessed by treatment duration
months
Measured: through study completion, estimated 2 years
Eligibility of subsequent therapies and the outcome, assessed by PFS
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 posted4 Feb 2019
- Study start11 Feb 2019
- Primary completion8 Dec 2020
- Study completion8 Dec 2020
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 Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 716 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- Chang Gung Memorial Hospital, Koo Foundation Sun Yat-Sen Cancer Center
- Responsible party
- Sponsor
- Investigators
- Hao-Wei Teng, MD, PhD, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03829852
- Sponsor's protocol ID
- 2018-12-013BC
- Status last verified
- Jul 2021
- First submitted
- 19 Jan 2019
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hsu HC, Huang KC, Chen WS, Jiang JK, Yang SH, Wang HS, Chang SC, Lan YT, Lin CC, Lin HH, Huang SC, Cheng HH, Yang TS, Chen CC, Chao Y, Teng HW. Preference criteria for regorafenib in treating refractory metastatic colorectal cancer are the small tumor burden, slow growth and poor/scanty spread. Sci Rep. 2021 Jul 28;11(1):15370. doi: 10.1038/s41598-021-94968-x.
PubMed 34321583
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigate the Real-life Treatment Outcome of Regorafenib in Treating mCRC Patients
- ClinicalTrials.gov ID
- NCT03829852
- Acronym / sponsor ID
- 2018-12-013BC
- Conditions
- Metastatic Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 716 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- Chang Gung Memorial Hospital, Koo Foundation Sun Yat-Sen Cancer Center
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 8 Dec 2020 (actual)
- Study completion
- 8 Dec 2020 (actual)
- First posted
- 4 Feb 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.
Regorafenib is currently the standard of care for refractory mCRC patients. Pivotal studies of regorafenib have proven the efficacy and safety, with a 28-day cycle (21 days on, 7 days off) and 160 mg dose given once daily.
In the clinic, patients often have some complicated condition. This study aims to perform retrospective medical chart review of mCRC patients who received regorafenib treatment in two medical centers in Taiwan to examine treatment effectiveness in the routine clinical practice setting.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- mCRC patients who received regorafenib treatment in Taipei Veterans General Hospital and Chang Gung Memorial Hospital Linkou, Taiwan
Key inclusion criteria (1 listed)
- mCRC patients who received at least one dose of regorafenib treatment
Key exclusion criteria (3 listed)
- <=20 y/o
- Patients who did not receive regorafenib treatment will be excluded from the analysis
- Patients with incomplete medical records that are deemed ineligible for analysis by investigator
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 |
|---|---|---|
| RegorafenibTreatment was performed based on physician's discretion | Drug | – |
Primary outcome
Effectiveness of regorafenib use in routine clinical practice setting, assessed by overall survival (OS)
Time frame: through study completion, estimated 2 years
months
Effectiveness of regorafenib use in routine clinical practice setting, assessed by progression free survival (PFS)
Time frame: through study completion, estimated 2 years
months
Effectiveness of regorafenib use in routine clinical practice setting, assessed by time to progression (TTP)
Time frame: through study completion, estimated 2 years
months
Effectiveness of regorafenib use in routine clinical practice setting, assessed by tumor response
Time frame: through study completion, estimated 2 years
percentage
6 secondary outcomes
Safety of regorafenib use in routine clinical practice setting, assessed by incidence of adverse events (AEs)
Time frame: through study completion, estimated 2 years
Safety of regorafenib use in routine clinical practice setting, assessed by initial dose
Time frame: through study completion, estimated 2 years
Safety of regorafenib use in routine clinical practice setting, assessed by dose intensity during the first 2 cycles
Time frame: through study completion, estimated 2 years
Eligibility of subsequent therapies and the outcome, assessed by type of treatment (anti-epithelial growth factor receptor [EGFR], anti-vascular endothelial growth factor [VEGF], and/or chemotherapy agents)
Time frame: through study completion, estimated 2 years
Eligibility of subsequent therapies and the outcome, assessed by treatment duration
Time frame: through study completion, estimated 2 years
Eligibility of subsequent therapies and the outcome, assessed by PFS
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 23 Jul 2021.
- Derived from this study: PubMed 34321583Hsu HC, Huang KC, Chen WS, Jiang JK, Yang SH, Wang HS, Chang SC, Lan YT, Lin CC, Lin HH, Huang SC, Cheng HH, Yang TS, Chen CC, Chao Y, Teng HW. Preference criteria for regorafenib in treating refractory metastatic colorectal cancer are the small tumor burden, slow growth and poor/scanty spread. Sci Rep. 2021 Jul 28;11(1):15370. doi: 10.1038/s41598-021-94968-x.
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CRC
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.
Hao-Wei Teng, MD, PhD principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Colorectal Cancer, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 1 inclusion and 3 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 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Effectiveness of regorafenib use in routine clinical practice setting, assessed by overall survival (OS) (time frame: through study completion, estimated 2 years). The study lists 4 primary outcomes in all. 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 NCT03829852, 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 23 Jul 2021.