The ROAM/EORTC-1308 trial: Radiation versus Observation following surgical resection of Atypical Meningioma: study protocol for a randomised controlled trial

Autor: Jacqui Vinten, Brian Haylock, Helen Gillard, Helen Hickey, Michael D. Jenkinson, Seamus Looby, Conor Mallucci, Helen Bulbeck, Michael A. Farrell, Bridget Young, Mattheus Preusser, Damien C. Weber, Carrol Gamble, Mohsen Javadpour, Kumar Das, Dyfrig A. Hughes
Přispěvatelé: University of Zurich, Jenkinson, Michael D
Jazyk: angličtina
Rok vydání: 2015
Předmět:
Time Factors
Survival
Cost-Benefit Analysis
medicine.medical_treatment
Medicine (miscellaneous)
Neurosurgical Procedures
law.invention
Study Protocol
Clinical Protocols
Quality of life
Randomized controlled trial
law
Meningeal Neoplasms
Medicine
2736 Pharmacology (medical)
Pharmacology (medical)
Stage (cooking)
610 Medicine & health
Outcome
Atypical meningioma
2701 Medicine (miscellaneous)
Health Care Costs
Magnetic Resonance Imaging
10044 Clinic for Radiation Oncology
Europe
Treatment Outcome
Research Design
Disease Progression
Quality-Adjusted Life Years
Neurosurgery
Meningioma
medicine.medical_specialty
Disease-Free Survival
Predictive Value of Tests
Humans
Radiotherapy
business.industry
medicine.disease
Surgery
Optic nerve sheath meningioma
Quality-adjusted life year
Radiation therapy
Quality of Life
Radiotherapy
Adjuvant
Dose Fractionation
Radiation
Cranial Irradiation
Neoplasm Recurrence
Local
business
Zdroj: TRIALS
Jenkinson, Michael D; Javadpour, Mohsen; Haylock, Brian J; Young, Bridget; Gillard, Helen; Vinten, Jacqui; Bulbeck, Helen; Das, Kumar; Farrell, Michael; Looby, Seamus; Hickey, Helen; Preusser, Mattheus; Mallucci, Conor L; Hughes, Dyfrig; Gamble, Carrol; Weber, Damien Charles (2015). The ROAM/EORTC-1308 trial: Radiation versus Observation following surgical resection of Atypical Meningioma: study protocol for a randomised controlled trial. Trials, 16(519), p. 519. BioMed Central 10.1186/s13063-015-1040-3
Trials
DOI: 10.1186/s13063-015-1040-3
Popis: BACKGROUND Atypical meningiomas are an intermediate grade brain tumour with a recurrence rate of 39-58 %. It is not known whether early adjuvant radiotherapy reduces the risk of tumour recurrence and whether the potential side-effects are justified. An alternative management strategy is to perform active monitoring with magnetic resonance imaging (MRI) and to treat at recurrence. There are no randomised controlled trials comparing these two approaches. METHODS/DESIGN A total of 190 patients will be recruited from neurosurgical/neuro-oncology centres across the United Kingdom, Ireland and mainland Europe. Adult patients undergoing gross total resection of intracranial atypical meningioma are eligible. Patients with multiple meningioma, optic nerve sheath meningioma, previous intracranial tumour, previous cranial radiotherapy and neurofibromatosis will be excluded. Informed consent will be obtained from patients. This is a two-stage trial (both stages will run in parallel): Stage 1 (qualitative study) is designed to maximise patient and clinician acceptability, thereby optimising recruitment and retention. Patients wishing to continue will proceed to randomisation. Stage 2 (randomisation) patients will be randomised to receive either early adjuvant radiotherapy for 6 weeks (60 Gy in 30 fractions) or active monitoring. The primary outcome measure is time to MRI evidence of tumour recurrence (progression-free survival (PFS)). Secondary outcome measures include assessing the toxicity of the radiotherapy, the quality of life, neurocognitive function, time to second line treatment, time to death (overall survival (OS)) and incremental cost per quality-adjusted life year (QALY) gained. DISCUSSION ROAM/EORTC-1308 is the first multi-centre randomised controlled trial designed to determine whether early adjuvant radiotherapy reduces the risk of tumour recurrence following complete surgical resection of atypical meningioma. The results of this study will be used to inform current neurosurgery and neuro-oncology practice worldwide. TRIAL REGISTRATION ISRCTN71502099 on 19 May 2014.
Databáze: OpenAIRE
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