148 Using real‑world data from GlioCova to assess the feasibility and revise the design of the ARISTOCRAT trial in recurrent glioblastoma

Rákkutatás · Glioblastoma

The ARISTOCRAT trial was redesigned from a rolling phase II/III to a conventional randomised phase II with revised recruitment targets of 96‑120 patients based on real‑world data from GlioCova.

ARISTOCRAT is a blinded trial of cannabinoids with standard‑of‑care temozolomide in recurrent glioblastoma, which initially aimed to recruit 234 patients over 18 months. Recruitment started on 03‑Feb‑2023, and it soon became apparent, from screening and recruitment data, that our initial site feasibility data was not reflected in actual recruitment. Estimating the eligible population size for studies is a recognised challenge. National cancer data is difficult to access and does not include the detail required to judge specific trial eligibility. In view of these problems, we explored alternative methods to estimate recruitment.

Using real‑world data allowed a realistic feasibility assessment and prevented potential study failure due to overoptimistic recruitment targets.

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