Metastatic Colorectal Cancer
Conditions
Brief 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. 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.
Interventions
DRUGRegorafenib
Treatment was performed based on physician's discretion
Sponsors
Chang Gung Memorial Hospital
Koo Foundation Sun Yat-Sen Cancer Center
Taipei Veterans General Hospital, Taiwan
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of regorafenib use in routine clinical practice setting, assessed by progression free survival (PFS) | through study completion, estimated 2 years | months |
| Effectiveness of regorafenib use in routine clinical practice setting, assessed by overall survival (OS) | through study completion, estimated 2 years | months |
| Effectiveness of regorafenib use in routine clinical practice setting, assessed by tumor response | through study completion, estimated 2 years | percentage |
| Effectiveness of regorafenib use in routine clinical practice setting, assessed by time to progression (TTP) | through study completion, estimated 2 years | months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eligibility of subsequent therapies and the outcome, assessed by treatment duration | through study completion, estimated 2 years | months |
| Eligibility of subsequent therapies and the outcome, assessed by PFS | through study completion, estimated 2 years | months |
| 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) | through study completion, estimated 2 years | percentage |
| Safety of regorafenib use in routine clinical practice setting, assessed by incidence of adverse events (AEs) | through study completion, estimated 2 years | percentage |
| Safety of regorafenib use in routine clinical practice setting, assessed by initial dose | through study completion, estimated 2 years | percentage |
| Safety of regorafenib use in routine clinical practice setting, assessed by dose intensity during the first 2 cycles | through study completion, estimated 2 years | percentage |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory outcome:Clinical markers/ biomarkers as the potential predictive factor for regorafenib treatment outcome in overall cohort and long-term responders, assessed by patient characteristics | through study completion, estimated 2 years | correlation |
| Exploratory outcome: Image pattern as the potential predictive factor for regorafenib treatment outcome in overall cohort and long-term responders, assessed by changes in image patterns | through study completion, estimated 2 years | correlation |
| Exploratory outcome:Clinical markers/ biomarkers as the potential predictive factor for regorafenib treatment outcome in overall cohort and long-term responders, assessed by changes in carbohydrate antigen (CA19-9) levels | through study completion, estimated 2 years | correlation |
| Exploratory outcome:Clinical markers/ biomarkers as the potential predictive factor for regorafenib treatment outcome in overall cohort and long-term responders, assessed by changes in carcinoembryonic antigen (CEA) levels | through study completion, estimated 2 years | correlation |
Countries
Taiwan
Outcome results
None listed