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| ID | Type | Description | Link |
|---|---|---|---|
| SV1415AT | Other Identifier | Company internal |
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The purpose of this trial is to quantitatively assess the average amount of physical activity that patients are capable to perform while receiving regorafenib for the treatment of metastatic colorectal cancer. The assessment of this reference value, measured by CE (Conformité Européene)-certified pedometer and international physical activity questionnaire, will allow an estimation on the feasible amount of physical activity for patients in this therapeutic setting.
This study is available for patients who are included in the global non-interventional study CORRELATE (Safety and efficacy of regorafenib in metastatic colorectal cancer patients; NCT01843400) in Austria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical activity / Cohort 1 | The non influenced and non triggered habitual physical activity of patients will be assessed by pedometer and physical activity questionnaire. The study population will consist of patients with metastatic CRC (mCRC) who are included in the NIS CORRELATE, have been previously treated with other approved regimens for metastatic disease and for whom a decision has been made by the physician to treat with regorafenib according to local health authority approved label prior to and independent of the inclusion into this observational study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regorafenib (Stivarga, BAY73-4506) | Drug | Stivarga is available as tablets (40 mg). It is taken in four-week treatment cycles at a recommended starting dose of 160 mg once every day for three weeks, followed by a week off. |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of physical activity assessed by a pedometer (smartLAB) and an international physical activity questionnaire | At 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Relation of the amount of physical activity to QoL (Quality of Life) data assessed in CORRELATE (NCT02042144, 'Safety and Effectiveness of Regorafenib in Routine Clinical Practice Settings') | At 3 months | |
| Relation of the amount of physical activity to fatigue data assessed in CORRELATE (NCT02042144, 'Safety and Effectiveness of Regorafenib in Routine Clinical Practice Settings') |
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Inclusion Criteria:
Exclusion Criteria:
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Participants of NIS CORRELATE (NCT02042144, Safety and Effectiveness of Regorafenib in Routine Clinical Practice Settings) in Austria
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Kreuzschwestern Wels GmbH | Multiple Locations | 4600 | Austria |
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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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| At 3 months |
| Relation of the amount of physical activity to DCR (Disease Control Rate) data assessed in CORRELATE (NCT02042144, 'Safety and Effectiveness of Regorafenib in Routine Clinical Practice Settings') | At 3 months |
| Relation of the amount of physical activity to OS (Overall Survival) data assessed in CORRELATE (NCT02042144, 'Safety and Effectiveness of Regorafenib in Routine Clinical Practice Settings') | At 3 months |
| Relation of the amount of physical activity to PFS (Progression Free Survival) data assessed in CORRELATE (NCT02042144, 'Safety and Effectiveness of Regorafenib in Routine Clinical Practice Settings') | At 3 months |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |