التفاصيل البيبلوغرافية
| العنوان: |
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 |
| المؤلفون: |
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 |
| المصدر: |
BMJ Open, Vol 14, Iss 3 (2024) |
| بيانات النشر: |
BMJ Publishing Group, 2024. |
| سنة النشر: |
2024 |
| المجموعة: |
LCC:Medicine |
| مصطلحات موضوعية: |
Medicine |
| الوصف: |
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. |
| نوع الوثيقة: |
article |
| وصف الملف: |
electronic resource |
| اللغة: |
English |
| تدمد: |
2044-6055 |
| Relation: |
https://bmjopen.bmj.com/content/14/3/e078926.full; https://doaj.org/toc/2044-6055 |
| DOI: |
10.1136/bmjopen-2023-078926 |
| URL الوصول: |
https://doaj.org/article/8f776f291e5c495981ce04e1bab3b6f3 |
| رقم الانضمام: |
edsdoj.8f776f291e5c495981ce04e1bab3b6f3 |
| قاعدة البيانات: |
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