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| Name | Class |
|---|---|
| Chang Gung Memorial Hospital | OTHER |
| Koo Foundation Sun Yat-Sen Cancer Center | OTHER |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regorafenib | Drug | Treatment was performed based on physician's discretion |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | correlation | through study completion, estimated 2 years |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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mCRC patients who received regorafenib treatment in Taipei Veterans General Hospital and Chang Gung Memorial Hospital Linkou, Taiwan
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| Name | Affiliation | Role |
|---|---|---|
| Hao-Wei Teng, MD, PhD | Taipei Veterans General Hospital, Taiwan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Taipei | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34321583 | Derived | 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. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C559147 | regorafenib |
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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 |
correlation |
| through study completion, estimated 2 years |
| 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 | correlation | through study completion, estimated 2 years |
| 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 | correlation | through study completion, estimated 2 years |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |