Outcome measures
death
RECURRENCE, RECRUITMENT, METASTASES, SECONDARY, PRIMARY CANCER
The primary outcome measure in REFINE is progression free survival (PFS). PFS is defined as the interval from randomisation to first evidence of local recurrence, new primary cancer, distant metastases (new or progression), or death from any cause, whichever occurs first. Analysis will be performed approximately 6 months after stage I recruitment has completed and will inform the design of the second stage.The following secondary outcome measures will be analysed:Overall survival (OS)Quality of Life (QoL) (EORTC QLQ-C30 and EQ-5D-5L)Treatment-related toxicityMean incremental cost per patientMean incremental QALYs per patient (calculated from EQ-5D-5L)Cost-utility analysis assessing cost-effectiveness of reduced versus standard frequency administrationFeasibility of recruitment to each cohort