This study is a prospective observational cohort study. The study will be conducted in routine clinical practice settings. It is planned to enroll 1000 patients with metastatic Colorectal Cancer (mCRC) who have been previously treated with other approved treatments 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. It is the aim of this observational cohort study to further characterize safety and effectiveness of regorafenib in routine clinical practice setting. Healthcare resource utilization in the routine provision of care is becoming increasingly important from a health economics and outcomes research perspective. Therefore, another aim of this observational cohort study is to capture healthcare resource associated with the management of treatment emergent adverse events in the real world setting. The primary objective of this study is to further characterize safety of regorafenib use in routine clinical practice settings. The secondary objective of this study is to assess the effectiveness of regorafenib in routine clinical practice settings as measured by Overall Survival (OS), Progression Free Survival (PFS) and Disease control rate (DCR). Health Related Quality of Life (HRQoL) Data will be collected in applicable countries.
Study Type
OBSERVATIONAL
Enrollment
1,034
Patients diagnosed with mCRC who have been previously treated with, or are not considered candidates for, other locally approved standard treatment(s) and for whom the decision has been made per investigator's routine treatment practice to prescribe regorafenib
Unnamed facility
Multiple Locations, Argentina
Unnamed facility
Multiple Locations, Austria
Unnamed facility
Multiple Locations, Czechia
Unnamed facility
Multiple Locations, Denmark
Unnamed facility
Multiple Locations, France
Unnamed facility
Multiple Locations, Italy
Unnamed facility
Multiple Locations, Luxembourg
Unnamed facility
Multiple Locations, Mexico
Unnamed facility
Multiple Locations, Netherlands
Unnamed facility
Multiple Locations, Singapore
...and 3 more locations
Incidence of all treatment-emergent adverse events (TEAE) - Patients will be monitored for TEAE using the NCI-CTCAE Version 4.3
Time frame: Up to 42 months
Overall Survival (OS), OS is defined as the time interval from the start of regorafenib therapy to death, due to any cause.
Time frame: Up to 42 months
Progression free survival (PFS) is defined as the time interval measured from the day of start with regorafenib treatment to (radiological or clinical) progression or death, whichever comes first.
Time frame: Up to 42 months
Disease control rate (DCR) - DCR is defined as percentage of patients, whose best response was not progressive disease (i.e. CR, PR or SD). Stable disease must be at least 6 weeks in duration.
Time frame: Up to 42 months
Quality of Life - HRQoL using PRO questionnaire EQ-5D (8) in applicable countries
Time frame: Up to 42 months
Healthcare resource utilization
Hospitalization (Date, Length), Concomitant medication and procedures and any other anticancer therapies
Time frame: Up to 42 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.