Neoplasms

Trial Purpose

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.

-  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.

-  Patients participating in an investigational program with interventions outside of routine clinical practice