Study protocol: PreOperative Brain Irradiation in Glioblastoma (POBIG) - A phase I trial.
Dose escalation
Glioblastoma
Hypofractionated
Neoadjuvant
POBIG
Preoperative
Radiotherapy
Trial
Journal
Clinical and translational radiation oncology
ISSN: 2405-6308
Titre abrégé: Clin Transl Radiat Oncol
Pays: Ireland
ID NLM: 101713416
Informations de publication
Date de publication:
Mar 2023
Mar 2023
Historique:
received:
17
11
2022
revised:
12
01
2023
accepted:
15
01
2023
entrez:
27
2
2023
pubmed:
28
2
2023
medline:
28
2
2023
Statut:
epublish
Résumé
Glioblastoma is a high-grade aggressive neoplasm whose outcomes have not changed in decades. In the current treatment pathway, tumour growth continues and remains untreated for several weeks post-diagnosis. Intensified upfront therapy could target otherwise untreated tumour cells and improve the treatment outcome. POBIG will evaluate the safety and feasibility of single-fraction preoperative radiotherapy for newly diagnosed glioblastoma, assessed by the maximum tolerated dose (MTD) and maximum tolerated irradiation volume (MTIV). POBIG is an open-label, dual-centre phase I dose and volume escalation trial that has received ethical approval. Patients with a new radiological diagnosis of glioblastoma will be screened for eligibility. This is deemed sufficient due to the high accuracy of imaging and to avoid treatment delay. Eligible patients will receive a single fraction of preoperative radiotherapy ranging from 6 to 14 Gy followed by their standard of care treatment comprising maximal safe resection and postoperative chemoradiotherapy (60 Gy/30 fr) with concurrent and adjuvant temozolomide). Preoperative radiotherapy will be directed to the part of the tumour that is highest risk for remaining as postoperative residual disease (hot spot). Part of the tumour will remain unirradiated (cold spot) and sampled separately for diagnostic purposes. Dose/volume escalation will be guided by a Continual Reassessment Method (CRM) model. Translational opportunities will be afforded through comparison of irradiated and unirradiated primary glioblastoma tissue. POBIG will help establish the role of radiotherapy in preoperative modalities for glioblastoma. NCT03582514 (clinicaltrials.gov).
Sections du résumé
Background
UNASSIGNED
Glioblastoma is a high-grade aggressive neoplasm whose outcomes have not changed in decades. In the current treatment pathway, tumour growth continues and remains untreated for several weeks post-diagnosis. Intensified upfront therapy could target otherwise untreated tumour cells and improve the treatment outcome. POBIG will evaluate the safety and feasibility of single-fraction preoperative radiotherapy for newly diagnosed glioblastoma, assessed by the maximum tolerated dose (MTD) and maximum tolerated irradiation volume (MTIV).
Methods
UNASSIGNED
POBIG is an open-label, dual-centre phase I dose and volume escalation trial that has received ethical approval. Patients with a new radiological diagnosis of glioblastoma will be screened for eligibility. This is deemed sufficient due to the high accuracy of imaging and to avoid treatment delay. Eligible patients will receive a single fraction of preoperative radiotherapy ranging from 6 to 14 Gy followed by their standard of care treatment comprising maximal safe resection and postoperative chemoradiotherapy (60 Gy/30 fr) with concurrent and adjuvant temozolomide). Preoperative radiotherapy will be directed to the part of the tumour that is highest risk for remaining as postoperative residual disease (hot spot). Part of the tumour will remain unirradiated (cold spot) and sampled separately for diagnostic purposes. Dose/volume escalation will be guided by a Continual Reassessment Method (CRM) model. Translational opportunities will be afforded through comparison of irradiated and unirradiated primary glioblastoma tissue.
Discussion
UNASSIGNED
POBIG will help establish the role of radiotherapy in preoperative modalities for glioblastoma.
Trial registration
UNASSIGNED
NCT03582514 (clinicaltrials.gov).
Identifiants
pubmed: 36845633
doi: 10.1016/j.ctro.2023.100585
pii: S2405-6308(23)00010-1
pmc: PMC9947330
doi:
Banques de données
ClinicalTrials.gov
['NCT03582514']
Types de publication
Journal Article
Langues
eng
Pagination
100585Subventions
Organisme : Cancer Research UK
ID : 28701
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/X014088/1
Pays : United Kingdom
Informations de copyright
© 2023 The Authors.
Déclaration de conflit d'intérêts
The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: POBIG is funded by UK Research and Innovation Medical Research Council (UKRI MRC). The research program of GB (Chief Investigator, senior author) is supported by Cancer Research UK RadNet Manchester.
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