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

Clicks: 3
ID: 326837
2026
Article Quality & Performance Metrics
Overall Quality
Not rated
Combines reader engagement with the AI quality analysis. This article has not been analysed, so there is no overall score — reader engagement is measured and shown alongside.
AI Quality Assessment
Not analyzed
Readership in this journal
Emerging

Ranked #204 of 219 articles by views in journal of neuro-oncology

Most read Least read

Bar heights use a square-root scale. Only the 120 most-read articles are drawn; the journal has 219 in total.

Mint this article as an NFT
Not yet minted

Create a permanent, verifiable on-chain record of this article on the Scimatic Network. The NFT is held in your Journament account, and you can withdraw it to your own wallet at any time.

5 SUSD one-off · no wallet required
Abstract
Abstract Introduction 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. Methods GlioCova is a comprehensive national dataset of all ∼56k adult primary brain tumour patients in England (2013-2018). We used this to estimate the number of eligible patients based on trial eligibility criteria for previous treatment (received sufficient adjuvant temozolomide and radiotherapy), IDH WT and MGMT methylation status. Results We estimated that <100 patients/year would be eligible for screening for ARISTOCRAT. Based on previous studies in this population, we would not anticipate more than 47% of screened patients to be randomised. Taken together, these data demonstrated that our initial recruitment targets were unrealistic. This prompted a statistical redesign of the trial from a rolling phase II/III to a conventional randomised phase II. This allowed revision of recruitment targets (96-120 patients) whilst maintaining 80% power to detect a 0.65 HR based on a 10% one-sided significance level within a practical and agreeable timeframe. Conclusions To the best of our knowledge, this is the first attempt to robustly address brain tumour trial recruitment using real-world data, and we believe this approach should be considered for future trials to avoid optimistic but unrealistic feasibility assessments that could lead to study failure.
Reference Key
openalex_W7204493713 Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors Joshua Savage, Divya Bhaskaran, Amanda Kirkham, Rhys Mant, Kerlann Le Calvez, Dr Fiona Collinson, Matthew Williams, Prof Lucinda Billingham, Susan Short
Journal journal of neuro-oncology
Year 2026
DOI
10.1093/neuonc/noag172.059
URL
Keywords Keywords not found

Citations

No citations found. To add a citation, contact the admin at info@scimatic.org

No comments yet. Be the first to comment on this article.