The purpose of this study is to assess the safety and tolerability of different dose-escalation approaches of regorafenib in mCRC patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
299
Spanish Cooperative Group for the Treatment of Digestive Tumors
Madrid, Spain
Percentage of patients with G3/G4 treatment-related AEs in each arm according to CTCAE v4.03 criteria.
Time frame: 30 months
Percentage of total administrated dose over the planned dose accomplished in each arm.
Time frame: 30 months
Dose intensity during the whole treatment.
Time frame: 30 months
Dose intensity during first two cycles.
Time frame: 2 months
Disease control rate (DCR)
Time frame: 30 months
Progression-free survival (PFS)
Time frame: 30 months
Time to treatment failure (TTF)
Time frame: 30 months
Overall survival (OS)
Time frame: 30 months
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