Impact of Metastatic Spine Score on Optimizing Enrollment Selectivity on a Multicenter Phase Two Randomized Controlled Trial

Objectives: A key barrier to successful trial completion is that enrolled patients do not reach the trial’s primary endpoint timeframe. This study examines the impact of a heuristic algorithm on screening patients who are otherwise at high risk for primary endpoint failure in a trial that has recently completed enrollment. Methods: The Spine Patient Optimal Radiosurgery Treatment for Symptomatic Metastatic Neoplasms (SPORTSMEN) multicenter Phase II randomized controlled trial examines the impact of radiation therapy on pain freedom in metastatic spine disease, with a primary endpoint of pain freedom at 3 months post-treatment. The rate of enrollment failure due to predicted inadequate prognosis (<3 mo) was compared before versus after implementation of the Metastatic Spine Score to assess the impact of this algorithm on trial enrollment. Results: A total of 136 patients were evaluated for trial enrollment. The first 64 patients were evaluated before the implementation of the Metastatic Spine Score, of whom 1 (2%) was excluded from enrollment due to an inadequate prognosis. The final 72 patients were evaluated after implementation of the Metastatic Spine Score; 15 patients (21%) were excluded from enrollment due to an inadequate prognosis. This difference in exclusion rate was statistically significant ( P =0.0003). Conclusions: In conclusion, the implementation of a heuristic algorithm during clinical trial enrollment had a significant impact on the prohibition of enrollment of patients at increased risk of primary endpoint failure. These results serve as a reminder of the importance of objectively quantifying prognosis and its impact on the risk of primary endpoint failure.