Phase 3 Randomized Trial of Prophylactic Cranial Irradiation With or Without Hippocampus Avoidance in SCLC (NCT01780675)

IntroductionTo compare neurocognitive functioning in patients with SCLC who received prophylactic cranial irradiation (PCI) or without hippocampus avoidance (HA).MethodsIn a multicenter, randomized phase 3 trial (NCT01780675), were to standard PCI HA-PCI of 25 Gy 10 fractions. Neuropsychological tests performed at baseline and 4, 8, 12, 18, 24 months after PCI. The primary end point was total recall on the Hopkins Verbal Learning Test—Revised 4 months; decline least five points from considered failure. Secondary included other cognitive outcomes, evaluation incidence, location brain metastases, overall survival.ResultsFrom April 2013 March 2018, 168 randomized. median follow-up time 26.6 months. In both treatment arms, 70% had limited disease characteristics well balanced. Decline Test-Revised score not significantly different between arms: 29% 28% dropped greater than equal (p = 1.000). Performance measuring memory, executive function, attention, motor processing speed did change over groups. survival 0.43). cumulative incidence metastases 2 years 20% (95% confidence interval: 12%–29%) for arm 16% 7%–24%) arm.ConclusionsThis find lower probability receiving compared conventional No increase observed arm.