Regorafenib in Taiwan Metastatic Colorectal Cancer (mCRC) Patients

Study Overview
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Brief Summary
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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.

Official Title
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Investigate the Real-life Treatment Outcome of Regorafenib in Treating mCRC Patients

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Drug: Regorafenib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: mCRC patients who received at least one dose of regorafenib treatment Exclusion Criteria: <=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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Regorafenib|Treatment was performed based on physician's discretion|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of regorafenib use in routine clinical practice setting, assessed by overall survival (OS) | months | through study completion, estimated 2 years | 
| Effectiveness of regorafenib use in routine clinical practice setting, assessed by progression free survival (PFS) | months | through study completion, estimated 2 years | 
| Effectiveness of regorafenib use in routine clinical practice setting, assessed by time to progression (TTP) | months | through study completion, estimated 2 years | 
| Effectiveness of regorafenib use in routine clinical practice setting, assessed by tumor response | percentage | through study completion, estimated 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of regorafenib use in routine clinical practice setting, assessed by incidence of adverse events (AEs) | percentage | through study completion, estimated 2 years | 
| Safety of regorafenib use in routine clinical practice setting, assessed by initial dose | percentage | 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 | 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 | through study completion, estimated 2 years | 
| Eligibility of subsequent therapies and the outcome, assessed by treatment duration | months | through study completion, estimated 2 years | 
| Eligibility of subsequent therapies and the outcome, assessed by PFS | months | through study completion, estimated 2 years |