Colorectal Neoplasms
Conditions
Keywords
Stivarga / Regorafenib / Metastatic Colorectal Cancer / Metastatic or unresectable locally advanced GIST (Gastrointestinal stromal tumors)
Brief summary
To investigate and collect post-marketing data on the safety of Stivarga in real world practice in its registered indication(s) as required by Health Authority.
Interventions
DRUGRegorafenib (Stivarga,BAY73-4506)
Patients treated by Physician with Stivarga under approved local prescriptions
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Inclusion Criteria: * Signed and dated informed consent * Patients diagnosed with histologically confirmed metastatic colorectal cancer and/or metastatic or unresectable locally advanced gastrointestinal stromal tumors and/or HCC who have been previously treated with sorafenib by physician * Patients who are prescribed with Stivarga tablet 40mg(Regorafenib) for the first time *
Exclusion criteria
* Patients participating in an investigational program with interventions outside of routine clinical practice * All contra-indications according to the local marketing authorization have to be considered.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with serious adverse events | Up to 30 days after terminating treatment | Every 2 months (monthly safety assessment within first two cycles) |
| Percentage of patients with adverse drug reactions (ADRs) | Up to 30 days after terminating treatment | Every 2 months (monthly safety assessment within first two cycles) |
Secondary
| Measure | Time frame |
|---|---|
| Overall response | Up to 6 years |
| Progression free survival (PFS) | Up to 6 years |
| Overall survival (OS) | Up to 6 years |
Countries
South Korea
Outcome results
None listed