Brain Re-Irradiation Or Chemotherapy: a phase II randomised trial of re-irradiation and chemotherapy in patients with recurrent glioblastoma (BRIOChe) – protocol for a multi-centre open-label randomised trial
Introduction Glioblastoma (GBM) is the most common adult primary malignant brain tumour. The condition is incurable and, despite aggressive treatment at first presentation, almost all tumours recur after a median of 7 months. The aim of treatment at recurrence is to prolong survival and maintain hea...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2024-03-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/14/3/e078926.full |
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| author | Stuart Currie Alexandra Smith David Sebag-Montefiore Helen Bulbeck Jane Hughes Susan Short Eleanor M Hudson Samantha Noutch Catherine Parbutt Louise Murray Joanne Webster Sarah R Brown Florien W Boele Omar Al-Salihi Helen Baines Sharon Fernandez John Lilley Finbar Slevin |
| author_facet | Stuart Currie Alexandra Smith David Sebag-Montefiore Helen Bulbeck Jane Hughes Susan Short Eleanor M Hudson Samantha Noutch Catherine Parbutt Louise Murray Joanne Webster Sarah R Brown Florien W Boele Omar Al-Salihi Helen Baines Sharon Fernandez John Lilley Finbar Slevin |
| author_sort | Stuart Currie |
| collection | DOAJ |
| description | Introduction Glioblastoma (GBM) is the most common adult primary malignant brain tumour. The condition is incurable and, despite aggressive treatment at first presentation, almost all tumours recur after a median of 7 months. The aim of treatment at recurrence is to prolong survival and maintain health-related quality of life (HRQoL). Chemotherapy is typically employed for recurrent GBM, often using nitrosourea-based regimens. However, efficacy is limited, with reported median survivals between 5 and 9 months from recurrence. Although less commonly used in the UK, there is growing evidence that re-irradiation may produce survival outcomes at least similar to nitrosourea-based chemotherapy. However, there remains uncertainty as to the optimum approach and there is a paucity of available data, especially with regards to HRQoL. Brain Re-Irradiation Or Chemotherapy (BRIOChe) aims to assess re-irradiation, as an acceptable treatment option for recurrent IDH-wild-type GBM.Methods and analysis BRIOChe is a phase II, multi-centre, open-label, randomised trial in patients with recurrent GBM. The trial uses Sargent’s three-outcome design and will recruit approximately 55 participants from 10 to 15 UK radiotherapy sites, allocated (2:1) to receive re-irradiation (35 Gy in 10 daily fractions) or nitrosourea-based chemotherapy (up to six, 6-weekly cycles). The primary endpoint is overall survival rate for re-irradiation patients at 9 months. There will be no formal statistical comparison between treatment arms for the decision-making primary analysis. The chemotherapy arm will be used for calibration purposes, to collect concurrent data to aid interpretation of results. Secondary outcomes include HRQoL, dexamethasone requirement, anti-epileptic drug requirement, radiological response, treatment compliance, acute and late toxicities, progression-free survival.Ethics and dissemination BRIOChe obtained ethical approval from Office for Research Ethics Committees Northern Ireland (reference no. 20/NI/0070). Final trial results will be published in peer-reviewed journals and adhere to the ICMJE guidelines.Trial registration number ISRCTN60524. |
| first_indexed | 2024-04-25T01:24:51Z |
| format | Article |
| id | doaj.art-8f776f291e5c495981ce04e1bab3b6f3 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2025-03-17T01:57:57Z |
| publishDate | 2024-03-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-8f776f291e5c495981ce04e1bab3b6f32025-02-14T11:10:14ZengBMJ Publishing GroupBMJ Open2044-60552024-03-0114310.1136/bmjopen-2023-078926Brain Re-Irradiation Or Chemotherapy: a phase II randomised trial of re-irradiation and chemotherapy in patients with recurrent glioblastoma (BRIOChe) – protocol for a multi-centre open-label randomised trialStuart Currie0Alexandra Smith1David Sebag-Montefiore2Helen Bulbeck3Jane Hughes4Susan Short5Eleanor M Hudson6Samantha Noutch7Catherine Parbutt8Louise Murray9Joanne Webster10Sarah R Brown11Florien W Boele12Omar Al-Salihi13Helen Baines14Sharon Fernandez15John Lilley16Finbar Slevin17Department of Radiology, Leeds General Infirmary, Leeds, UKLeeds Cancer Research UK Clinical Trials Unit, University of Leeds, Leeds, UKLeeds Institute of Medical Research at St James’s, University of Leeds, Leeds, UKBrainstrust, Cowes, UKLeeds Institute of Medical Research at St James’s, University of Leeds, Leeds, UKLeeds Institute of Medical Research at St James’s, University of Leeds, Leeds, UKClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UKLeeds Cancer Research UK Clinical Trials Unit, University of Leeds, Leeds, UKPharmacy, Leeds Teaching Hospitals NHS Trust, Leeds, UKLeeds Institute of Medical Research at St James’s, University of Leeds, Leeds, UKLeeds Cancer Research UK Clinical Trials Unit, University of Leeds, Leeds, UKLeeds Cancer Research UK Clinical Trials Unit, University of Leeds, Leeds, UKLeeds Institute of Medical Research at St James’s, University of Leeds, Leeds, UKGuy’s and St Thomas’ Hospitals NHS Trust, London, UKNational Radiotherapy Trials QA (RTTQA) Group, Mount Vernon Cancer Centre, Northwood, UKLeeds Institute of Medical Research at St James’s, University of Leeds, Leeds, UKLeeds Teaching Hospitals NHS Trust, Leeds, UKLeeds Institute of Medical Research, University of Leeds, Leeds, UKIntroduction Glioblastoma (GBM) is the most common adult primary malignant brain tumour. The condition is incurable and, despite aggressive treatment at first presentation, almost all tumours recur after a median of 7 months. The aim of treatment at recurrence is to prolong survival and maintain health-related quality of life (HRQoL). Chemotherapy is typically employed for recurrent GBM, often using nitrosourea-based regimens. However, efficacy is limited, with reported median survivals between 5 and 9 months from recurrence. Although less commonly used in the UK, there is growing evidence that re-irradiation may produce survival outcomes at least similar to nitrosourea-based chemotherapy. However, there remains uncertainty as to the optimum approach and there is a paucity of available data, especially with regards to HRQoL. Brain Re-Irradiation Or Chemotherapy (BRIOChe) aims to assess re-irradiation, as an acceptable treatment option for recurrent IDH-wild-type GBM.Methods and analysis BRIOChe is a phase II, multi-centre, open-label, randomised trial in patients with recurrent GBM. The trial uses Sargent’s three-outcome design and will recruit approximately 55 participants from 10 to 15 UK radiotherapy sites, allocated (2:1) to receive re-irradiation (35 Gy in 10 daily fractions) or nitrosourea-based chemotherapy (up to six, 6-weekly cycles). The primary endpoint is overall survival rate for re-irradiation patients at 9 months. There will be no formal statistical comparison between treatment arms for the decision-making primary analysis. The chemotherapy arm will be used for calibration purposes, to collect concurrent data to aid interpretation of results. Secondary outcomes include HRQoL, dexamethasone requirement, anti-epileptic drug requirement, radiological response, treatment compliance, acute and late toxicities, progression-free survival.Ethics and dissemination BRIOChe obtained ethical approval from Office for Research Ethics Committees Northern Ireland (reference no. 20/NI/0070). Final trial results will be published in peer-reviewed journals and adhere to the ICMJE guidelines.Trial registration number ISRCTN60524.https://bmjopen.bmj.com/content/14/3/e078926.full |
| spellingShingle | Stuart Currie Alexandra Smith David Sebag-Montefiore Helen Bulbeck Jane Hughes Susan Short Eleanor M Hudson Samantha Noutch Catherine Parbutt Louise Murray Joanne Webster Sarah R Brown Florien W Boele Omar Al-Salihi Helen Baines Sharon Fernandez John Lilley Finbar Slevin Brain Re-Irradiation Or Chemotherapy: a phase II randomised trial of re-irradiation and chemotherapy in patients with recurrent glioblastoma (BRIOChe) – protocol for a multi-centre open-label randomised trial BMJ Open |
| title | Brain Re-Irradiation Or Chemotherapy: a phase II randomised trial of re-irradiation and chemotherapy in patients with recurrent glioblastoma (BRIOChe) – protocol for a multi-centre open-label randomised trial |
| title_full | Brain Re-Irradiation Or Chemotherapy: a phase II randomised trial of re-irradiation and chemotherapy in patients with recurrent glioblastoma (BRIOChe) – protocol for a multi-centre open-label randomised trial |
| title_fullStr | Brain Re-Irradiation Or Chemotherapy: a phase II randomised trial of re-irradiation and chemotherapy in patients with recurrent glioblastoma (BRIOChe) – protocol for a multi-centre open-label randomised trial |
| title_full_unstemmed | Brain Re-Irradiation Or Chemotherapy: a phase II randomised trial of re-irradiation and chemotherapy in patients with recurrent glioblastoma (BRIOChe) – protocol for a multi-centre open-label randomised trial |
| title_short | Brain Re-Irradiation Or Chemotherapy: a phase II randomised trial of re-irradiation and chemotherapy in patients with recurrent glioblastoma (BRIOChe) – protocol for a multi-centre open-label randomised trial |
| title_sort | brain re irradiation or chemotherapy a phase ii randomised trial of re irradiation and chemotherapy in patients with recurrent glioblastoma brioche protocol for a multi centre open label randomised trial |
| url | https://bmjopen.bmj.com/content/14/3/e078926.full |
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