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| ID | Type | Description | Link |
|---|---|---|---|
| SV1313 | Other Identifier | Company internal |
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The purpose of the study is to investigate the safety and effectiveness of Stivarga in patients with metastatic colorectal carcinoma in routine use in Germany. The study is purely observational, only data from routine treatment are to be collected. The treatment and treatment conditions are solely at discretion of the treating physician.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regorafenib | Patients treated with Stivarga as 3rd or 4th line treatment, no intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regorafenib (Stivarga, BAY 73-4506) | Drug | As determined by the treating physician |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | after 40 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | after 40 months | |
| Time to progression | after 40 months | |
| Disease control rate (DCR) |
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Inclusion Criteria:´
Exclusion Criteria:
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Female and male patients ≥ 18 years of age with a diagnosis of metastatic colorectal carcinoma (mCRC) will be enrolled in the sites during the enrollment period. All treatment decisions prior inclusion of a patient as well as during the observation must be made by the investigator based on his regular medical practice. Patients must give written informed consent prior to documentation.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Germany |
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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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Disease control rate (DCR) is defined as percentage of patients, whose best response was not progressive disease (i.e. complete response, partial response or stable disease). |
| after 40 months |
| Duration of Stivarga treatment | Duration of Stivarga treatment is defined as the time interval from start of Stivarga therapy to the date of permanent discontinuation of Stivarga therapy (regardless of the reason for discontinuation) | after 40 months |
| Tumor status at different visits | The tumor status at different visits will be evaluated according to the categories "complete response", "partial response", "stable disease", "progressive disease by clinical judgment", "progressive disease measurement proven", "unknown" and "not applicable". The best overall response will be analyzed providing absolute and relative frequencies of the tumor status categories. | after 40 months |
| Incidence of treatment emergent adverse events (TEAE) | Detailed information collected for each TEAE will include: a description of the event, duration, whether the TEAE was serious, relationship to Stivarga, action taken, clinical outcome. Summary tables will present the number of subjects observed with TEAEs and corresponding percentages. Additional subcategories will be based on event intensity and relationship to study drug. | after 18 and 40 months |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |