Study design and patients
Cancer
SECONDARY, CANCER
Eligibility details of this phase 2 multicenter, randomized, double‐blind trial have been previously published.Written informed consent was provided by all patients before undergoing any study‐specific procedures. The study protocol was approved by relevant institutional review boards and was conducted in accordance with the principles of the World Medical Association Declaration of Helsinki.Patients were randomly assigned (1:1) to receive a starting dose of lenvatinib 18 mg/day or 24 mg/day. Randomization of masked lenvatinib dose packs was performed centrally by an interactive voice‐ and webresponse system. Double‐blind lenvatinib dosing was used to minimize patient and investigator bias. Patients were stratified by age (≤ 65 years vs. > 65 years) and ECOG PS (0 vs. 1 or 2).A secondary objective of Study 211 was to evaluate the effect of lenvatinib treatment on HRQoL as measured by the EuroQol 5 Dimensions 3 Levels (EQ‐5D‐3L) and Functional Assessment of Cancer Therapy‐General (FACT‐G). HRQoL was assessed at baseline, every 8 weeks until Week 24, then every 16 weeks, and at the off‐treatment visit.