Purpose: Laser interstitial thermal therapy (LITT) is increasingly being used in the treatment of brain tumors, whereas high-quality evidence of its effectiveness is lacking. This pilot examined the feasibility of conducting a randomized controlled trial (RCT) in patients with irresectable newly diagnosed glioblastoma (nGBM), and generated data on technical feasibility and safety.
Methods: We included patients with irresectable nGBM with KPS ≥ 70 and feasible trajectories to ablate ≥ 70% of the tumor volume. Patients were initially randomized to receive either biopsy combined with LITT or biopsy alone, followed by chemoradiation (CRT). Randomization was stopped after 9 patients as the feasibility endpoint with respect to willingness to be randomized was met. Main endpoints were feasibility of performing an RCT, technical feasibility of LITT and safety. Follow-up was 3 months.
Results: A total of 15 patients were included, of which 10 patients received a biopsy followed by LITT and 5 patients a biopsy. Most patients were able to complete the follow-up procedures (93% clinical, 86% questionnaires, 78% MRI). Patients were planned within 3 weeks after consultation (median 12 days, range 8-16) and no delay was observed in referring patients for CRT (median 37 days, range 28-61). Two CD ≥ 3 complications occurred in the LITT arm and none in the biopsy arm.
Conclusion: An RCT to study the effectiveness of LITT in patients with an irresectable nGBM seems feasible with acceptable initial safety data. The findings from this pilot study helped to further refine the design of a larger full-scale multicenter RCT in the Netherlands. Protocol and study identifier: The current study is registered at clinicaltrials.gov (EMITT pilot study, NTR: NCT04596930).
Keywords: Glioblastoma; LITT; Laser ablation; Pilot; SLA.
© 2023. The Author(s).