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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

Hudson, Eleanor M ; Noutch, Samantha ; Webster, Joanne ; Brown, Sarah R ; Boele, Florien W ; Al-Salihi, Omar ; Baines, Helen ; Bulbeck, Helen ; Currie, Stuart ; Fernandez, Sharon ; Hughes, Jane ; Lilley, John ; Smith, Alexandra ; Parbutt, Catherine ; Slevin, Finbar ; Short, Susan ; Sebag-Montefiore, David ; Murray, Louise

BMJ open, 2024-03, Vol.14 (3), p.e078926-e078926 [Periódico revisado por pares]

England: British Medical Journal Publishing Group

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Título:
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
Autor: Hudson, Eleanor M ; Noutch, Samantha ; Webster, Joanne ; Brown, Sarah R ; Boele, Florien W ; Al-Salihi, Omar ; Baines, Helen ; Bulbeck, Helen ; Currie, Stuart ; Fernandez, Sharon ; Hughes, Jane ; Lilley, John ; Smith, Alexandra ; Parbutt, Catherine ; Slevin, Finbar ; Short, Susan ; Sebag-Montefiore, David ; Murray, Louise
Assuntos: Adult ; Brain ; Brain cancer ; Brain research ; Caregivers ; Chemotherapy ; Clinical Trials, Phase II as Topic ; Consent ; Glioblastoma - drug therapy ; Glioblastoma - radiotherapy ; Humans ; Medical prognosis ; Multicenter Studies as Topic ; Neoplasm Recurrence, Local - drug therapy ; Neurological oncology ; Oncology ; Patients ; Quality of Life ; Questionnaires ; Radiation oncology ; Radiation therapy ; RADIOTHERAPY ; Randomized Controlled Trials as Topic ; Re-Irradiation ; Toxicity ; Tumors
É parte de: BMJ open, 2024-03, Vol.14 (3), p.e078926-e078926
Notas: Protocol
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Descrição: IntroductionGlioblastoma (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 analysisBRIOChe 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 disseminationBRIOChe 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 numberISRCTN60524.
Editor: England: British Medical Journal Publishing Group
Idioma: Inglês

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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

England: British Medical Journal Publishing Group

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