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.
Adverse events
Brain cancer
Cannabinoids
Glioblastoma
Nabiximols
Overall survival
Progression free survival
Randomised phase II trial
Sativex
Temozolomide
Tumour
Journal
BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800
Informations de publication
Date de publication:
15 Jan 2024
15 Jan 2024
Historique:
received:
08
11
2023
accepted:
22
12
2023
medline:
16
1
2024
pubmed:
16
1
2024
entrez:
15
1
2024
Statut:
epublish
Résumé
Glioblastoma (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 ARISTOCRAT 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. 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. ISRCTN: 11460478. Gov: NCT05629702.
Sections du résumé
BACKGROUND
BACKGROUND
Glioblastoma (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
METHODS
METHODS
ARISTOCRAT 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
CONCLUSIONS
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 REGISTRATION
BACKGROUND
ISRCTN: 11460478.
CLINICALTRIALS
RESULTS
Gov: NCT05629702.
Identifiants
pubmed: 38225549
doi: 10.1186/s12885-023-11792-4
pii: 10.1186/s12885-023-11792-4
doi:
Banques de données
ClinicalTrials.gov
['NCT05629702']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
83Subventions
Organisme : Brain Tumour Charity
ID : GN-000705
Organisme : Brain Tumour Charity
ID : GN-000705
Organisme : Brain Tumour Charity
ID : GN-000705
Organisme : Brain Tumour Charity
ID : GN-000705
Organisme : Brain Tumour Charity
ID : GN-000705
Organisme : Brain Tumour Charity
ID : GN-000705
Organisme : Brain Tumour Charity
ID : GN-000705
Organisme : Brain Tumour Charity
ID : GN-000705
Informations de copyright
© 2024. The Author(s).
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