ROAM (EORTC 1308) : Radiation versus Observation following surgical resection of Atypical Meningioma: a randomised controlled trial (The ROAM trial)
Indication :

Méningiome


Sponsor :

EORTC


Phase :

autre


Traitement :

Radiotherapy versus Observation following surgery


Site :

CHUV


Contact(s) :
Dr Andreas Hottinger
Investigateur Principal

CHUV
Oncologie

Rue du Bugnon 46
Lausanne
1011

+41213146541
andreas.hottinger@chuv.ch

Primary objective :

To determine whether early adjuvant fractionated radiotherapy reduces the risk of tumour recurrence or death due to any cause compared to active monitoring in newly diagnosed atypical meningioma.


Inclusion criteria :

a) Histologically confirmed newly diagnosed solitary atypical meningioma (WHO grade II) based on the 2016 WHO criteria
b) Age >/= 16 years
c) All anatomical locations allowed except optic nerve sheath tumour
d) Complete resection (Simpson 1, 2 or 3) as assessed by the surgeon
e) Able to commence radiotherapy between within 12 weeks of surgery (ideally 8-12 weeks)
f) WHO performance status 0, 1 or 2
g) Women of reproductive potential must use effective contraception for the whole duration of the treatment
h) 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.


Exclusion criteria :

a) Neurofibromatosis type II (NF-2)
b) Optic nerve sheath tumours
c) Multiple meningiomas
d) Radiation-induced meningioma
e) 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
f) Previous intracranial tumour in the last 10 years treated with radiotherapy or chemotherapy
g) Pregnant or lactating women.