Table 1 Outcomes, measures and methods of analysis
From: Molecular profiling of advanced soft-tissue sarcomas: the MULTISARC randomized trial
Outcome | Hypothesis/outcome measure | Methods of analysis |
|---|---|---|
Primary outcome | ||
Feasibility of NGS | 80% of patients will present a validated sequencing report including a clinical recommendation from the MTB within 7 weeks from the receipt of the blood and tumor samples | Binomial test/ Confidence Interval |
Main secondary outcomes | ||
Overall survival (OS) | Improvement of OS in NGS arm | Kaplan-Meir/Log-rank test |
Progression-free survival (PFS) | Improvement of PFS in NGS arm | Kaplan-Meir/Log-rank test |
Patients with targetable genomic alterations | Count and proportion of patients | Confidence Interval |
Antitumor activity under targeted therapy (objective response, best overall response, disease control rate) | Count and proportion of patients following RECIST1.1 criteria. | Confidence Interval |