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The INTRAGO-II Phase 3 trial evaluated whether adding 30 Gy intraoperative radiotherapy (IORT) to surgery and standard chemoradiotherapy could improve outcomes in newly diagnosed glioblastoma. Of 411 patients assessed, 314 were randomized and 298 included in the full-analysis set (IORT n=161; standard care n=137). At median follow-up of 17.2 months, median progression-free survival was 11.0 months with IORT versus 11.4 months with standard care (HR 1.10; 95% CI 0.85–1.44; P=.47). Local recurrence was similar (72% vs 71%; P=.87). Grade 3–4 seizures occurred in 13% versus 7%, while radiation necrosis occurred in 7% versus 2%. Serious adverse events occurred in 65% versus 53% of patients. The addition of IORT therefore did not improve progression-free survival.
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The INTRAGO-II Phase 3 trial evaluated whether adding 30 Gy intraoperative radiotherapy (IORT) to surgery and standard chemoradiotherapy could improve outcomes in newly diagnosed glioblastoma. Of 411 patients assessed, 314 were randomized and 298 included in the full-analysis set (IORT n=161; standard care n=137). At median follow-up of 17.2 months, median progression-free survival was 11.0 months with IORT versus 11.4 months with standard care (HR 1.10; 95% CI 0.85–1.44; P=.47). Local recurrence was similar (72% vs 71%; P=.87). Grade 3–4 seizures occurred in 13% versus 7%, while radiation necrosis occurred in 7% versus 2%. Serious adverse events occurred in 65% versus 53% of patients. The addition of IORT therefore did not improve progression-free survival.
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