Atypical meningioma Cancer Benign neoplasm of meninges
Conditions
Interventions
The trial will randomise patients who have undergone gross total surgical resection of atypical (grade II) meningioma in a 1:1 ratio to either early radiotherapy (intervention) or active monitoring (
Sponsors
The Walton Centre NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 03/05/2017: 1. Histologically confirmed newly diagnosed solitary atypical meningioma (WHO grade II) based on the 2016 WHO criteria 2. Age >/= 16 years 3. All anatomical locations allowed except optic nerve sheath tumour 4. Complete resection (Simpson 1, 2 or 3) as assessed by the surgeon 5. Able to commence radiotherapy between within 12 weeks of surgery (ideally 8-12 weeks) 6. WHO performance status 0, 1 or 2 7. Women of reproductive potential must use effective contraception for the whole duration of the treatment 8. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial Previous inclusion criteria: 1. Histologically confirmed newly diagnosed solitary atypical meningioma (WHO grade II) based on the 2007 WHO criteria 2. Age 16 years or over 3. All anatomical locations allowed except optic nerve sheath tumour 4. Complete resection (Simpson grade I, II or III) as assessed by the surgeon 5. Able to commence radiotherapy between 8 and 12 weeks after surgery 6. WHO performance status 0-2
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 05/04/2019: 1. Neurofibromatosis type II (NF-2) 2. Optic nerve sheath tumours 3. Multiple meningiomas 4. Radiation-induced meningioma 5. Clinical evidence of second malignancy, except for cervix carcinoma in situ or basal cell carcinoma, and history of invasive malignancy unless treated with curative intent and the patient has been disease free for the last five years 6. Previous intracranial tumour in the last 10 years treated with radiotherapy or chemotherapy 7. Pregnant or lactating women. Previous exclusion criteria as of 03/05/2017: 1. Neurofibromatosis type II (NF-2) 2. Optic nerve sheath tumours 3. Multiple meningiomas 4. Radiation-induced meningioma 5. Clinical evidence of second malignancy, except for cervix carcinoma in situ or basal cell carcinoma, and history of invasive malignancy unless treated with curative intent and the patient has not been disease free for the last five years 6. Previous intracranial tumour 7. Pregnant or lactating women Previous exclusion criteria: 1. Neurofibromatosis type II (NF-2) 2. Multiple meningiomas 3. Previous radiotherapy to the brain or meninges interfering with the protocol treatment plan 4. Clinical evidence of second malignancies, except a history of cervix carcinoma in situ and/or basal cell carcinoma 5. Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 05/04/2019: Time to MRI evidence of tumour recurrence or death due to any cause (disease free survival [DFS]). (DFS will be counted from the date of surgery until the date of MRI evidence of tumour recurrence or death due to any cause. Only clear dural thickening as identified by the investigator is to be considered tumour.) Previous primary outcome measure: Time to MRI evidence of tumour recurrence [disease free survival (DFS)] is assessed at baseline, 6 and 12 months following surgery and annually thereafter for a minimum of 5 years post-surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 05/04/2019: 1. Toxicity of radiotherapy assessed by CTCAE (Common Terminology Criteria for Adverse Events) 2. Quality of life 3. Neurocognitive function (UK sites only) 4. Time to second line (salvage) treatment (surgery, radiotherapy, radiosurgery) 5. Time to death (overall survival [OS]) 6. Health economic analysis (incremental cost per QALY gained) (UK sites only) Previous secondary outcome measures: 1. Time to second line (salvage) treatment (surgery, radiotherapy, radiosurgery) 2. Time to death [overall survival (OS)] 3. Toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE) 4. Quality of life is measured using the EORTC C30 and BN20 questionnaires 5. Neurocognitive function is measured using patient testing at baseline and 24 months 6. Health economic analysis (incremental cost per QALY gained) (UK sites only) Patients will be assessed at baseline, 6 and 12 months following surgery and annually thereafter for a minimum of 5 years post-surgery unless otherwise stated. | — |
Countries
Australia, Austria, Belgium, England, France, Germany, Ireland, Italy, New Zealand, Northern Ireland, Scotland, Spain, Switzerland, United Kingdom, Wales
Contacts
Public ContactStephanie Willshaw
Outcome results
None listed