Trifluridine-tipiracil plus bevacizumab versus capecitabine plus bevacizumab as first-line treatment for patients with metastatic colorectal cancer ineligible for intensive therapy (SOLSTICE): a randomised, open-label phase 3 study.

Background: Trifluridine-tipiracil plus bevacizumab has shown efficacy in previous phase 2 studies including patients with unresectable metastatic colorectal cancer. We aimed to investigate first-line trifluridine-tipiracil plus bevacizumab versus capecitabine plus bevacizumab in patients with unresectable metastatic colorectal cancer ineligible for intensive treatment.

Methods: In this open-label, randomised, phase 3 study, we enrolled patients aged 18 years and older with histologically confirmed metastatic colorectal cancer, ineligible for full-dose doublet or triplet chemotherapy and curative resection across 25 countries and regions.

A Bayesian approach for event predictions in clinical trials with time-to-event outcomes.

In clinical trials with time-to-event outcome as the primary endpoint, the end of study date is often based on the number of observed events, which drives the statistical power and the sample size calculation. It is of great value for study sponsors to have a good understanding of the recruitment process and the event milestones to manage the logistical tasks, which require a considerable amount of resources. The objective of the proposed statistical approach is to predict, as accurately as possible, the timing of an analysis planned once a target number of events is collected.