Evidence map›Paper›PMID 38225549›Full record

ArticleBMC cancer2024

A randomised phase II trial of temozolomide with or without cannabinoids in patients with recurrent glioblastoma (ARISTOCRAT): protocol for a multi-centre, double-blind, placebo-controlled trial.

Divyalakshmi Bhaskaran, Joshua Savage, Amit Patel, Fiona Collinson, Rhys Mant, Florien Boele, Lucy Brazil, Sara Meade, Peter Buckle, Siân Lax and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05629702 (A Randomised Controlled Phase II Trial of Temozolomide With or Without Cannabinoids in Patients With Recurrent Glioblastoma), which is not on this map. Cited by 20 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 2 pooled it
9.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05629702 phase2recruitingnot on this map

A Randomised Controlled Phase II Trial of Temozolomide With or Without Cannabinoids in Patients With Recurrent Glioblastoma

TypeinterventionalSponsorUniversity of BirminghamRan2023 to 2027Enrolled120ConditionsGlioblastoma, Brain Tumor, Cannabis, Brain Tumor, RecurrentArmsNabiximols, Temozolomide, Nabiximols-matched placebo
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 2 syntheses or guidelines pooled it, 22 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Medical Cannabis and the Hallmarks of Cancer: A Critical Narrative Review.International journal of molecular sciences · 2026
    Review
  5. Article
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  8. Article
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  10. Article
  11. Review
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  18. Cannabinoids in the treatment of glioblastoma.Pharmacological reports : PR · 2024
    Review
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  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 7 institutions in 1 country.

Divyalakshmi BhaskaranSchool of Medicine, University of Leeds, LS2 9JT, Leeds, UK.
Joshua SavageCancer Research UK Clinical Trials Unit (CRCTU), Institute of Cancer & Genomic Sciences, University of Birmingham, Birmingham, UK.
Amit PatelCancer Research UK Clinical Trials Unit (CRCTU), Institute of Cancer & Genomic Sciences, University of Birmingham, Birmingham, UK.
Fiona CollinsonSchool of Medicine, University of Leeds, LS2 9JT, Leeds, UK.
Rhys MantCancer Research UK Clinical Trials Unit (CRCTU), Institute of Cancer & Genomic Sciences, University of Birmingham, Birmingham, UK.
Florien BoeleSchool of Medicine, University of Leeds, LS2 9JT, Leeds, UK.
Lucy BrazilGuy's and St Thomas' NHS Foundation Trust, London, UK.
Sara MeadeUniversity Hospitals Birmingham Foundation Trust, Birmingham, UK.
Peter BuckleThe Brain Tumour Charity, Hampshire, UK.
Siân LaxCancer Research UK Clinical Trials Unit (CRCTU), Institute of Cancer & Genomic Sciences, University of Birmingham, Birmingham, UK.
Lucinda BillinghamCancer Research UK Clinical Trials Unit (CRCTU), Institute of Cancer & Genomic Sciences, University of Birmingham, Birmingham, UK.
Susan C ShortSchool of Medicine, University of Leeds, LS2 9JT, Leeds, UK. S.C.Short@leeds.ac.uk.
University of Birmingham · GBUniversity of Leeds · GBCancer Research UK Clinical Trials Unit · GBBrain Tumour Charity · GBGuy's and St Thomas' NHS Foundation Trust · GBLeeds Teaching Hospitals NHS Trust · GBUniversity Hospitals Birmingham NHS Foundation Trust · GB

Funding

Brain Tumour Charity GN-000705Cancer Research UK 25354
6 · The paper itself

Abstract

backgroundGlioblastoma (GBM) is the most common adult malignant brain tumour, with an incidence of 5 per 100,000 per year in England. Patients with tumours showing O

methodsARISTOCRAT is a phase II, multi-centre, double-blind, placebo-controlled, randomised trial to assess cannabinoids in patients with recurrent MGMT methylated GBM who are suitable for treatment with TMZ. Patients who have relapsed ≥ 3 months after completion of initial first-line treatment will be randomised 2:1 to receive either nabiximols or placebo in combination with TMZ. The primary outcome is overall survival time defined as the time in whole days from the date of randomisation to the date of death from any cause. Secondary outcomes include overall survival at 12 months, progression-free survival time, HRQoL (using patient reported outcomes from QLQ-C30, QLQ-BN20 and EQ-5D-5L questionnaires), and adverse events. DISCUSSION: Patients with recurrent MGMT promoter methylated GBM represent a relatively good prognosis sub-group of patients with GBM. However, their median survival remains poor and, therefore, more effective treatments are needed. The phase II design of this trial was chosen, rather than phase III, due to the lack of data currently available on cannabinoid efficacy in this setting. A randomised, double-blind, placebo-controlled trial will ensure an unbiased robust evaluation of the treatment and will allow potential expansion of recruitment into a phase III trial should the emerging phase II results warrant this development.

trial registrationISRCTN: 11460478. CLINICALTRIALS: Gov: NCT05629702.

Indexed as

Brain NeoplasmsCannabinoidsGlioblastomaAdultAntineoplastic Agents, AlkylatingClinical Trials, Phase II as TopicHumansMulticenter Studies as TopicNeoplasm Recurrence, LocalQuality of LifeRandomized Controlled Trials as TopicTemozolomideAntineoplastic Agents, AlkylatingCannabinoidsTemozolomideAdverse eventsBrain cancerCannabinoidsGlioblastomaNabiximolsOverall survivalProgression free survivalRandomised phase II trialSativexTemozolomideTumour

Identifiers

PMID38225549
PMCPMC10790538
OpenAlexW4390876387

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.