Radiotherapy versus Observation after surgical resection of an Atypical Meningioma: a randomized controlled trial (Radiation versus Observation following surgical resection of Atypical Meningioma: a randomized controlled trial), ROAM trial.
Summary description of the study
This clinical study aims to answer the question of whether radiotherapy accompanied by active medical follow-up (magnetic resonance imaging post-radiotherapy at regular intervals) after the operation of an atypical meningioma for an adult patient should be applied or not, and whether this reduces the risk of recurrence. Patients participating in the ROAM study will be randomly assigned to one of the two arms of the study: radiotherapy with active clinical follow-up or active clinical follow-up without radiotherapy. Radiotherapy: patients assigned to the "radiotherapy" group will receive, in addition to the active medical follow-up mentioned below, radiotherapy for a duration of six weeks that will start approximately 8 to 12 weeks after the operation. Active medical follow-up: the medical follow-up will be identical for both groups. Patients will undergo an MRI (magnetic resonance imaging) 4 to 6 weeks after the operation. An MRI will be repeated 6 months and 12 months after the operation and then annually for at least the next 4 years. At each visit, patients will be asked about any problems that may have occurred. They will also be asked to fill out a questionnaire about their health status.
(BASEC)
Intervention under investigation
Radiotherapy (60Gy in 30 fractions, one fraction of 2 Gy per day, 5 days per week)
(BASEC)
Disease under investigation
Atypical Meningioma Meningiomas are brain tumors that develop in the tissues surrounding the brain. Most of these tumors are benign (meaning they are not cancerous) and can be treated by surgery alone. Very rarely, these tumors can be malignant (cancerous) and require treatment by surgery and radiotherapy. There is a third group, called atypical meningiomas, which falls into an intermediate category between benign and malignant tumors. Following a surgical intervention, there is a risk that atypical meningiomas may begin to grow again.
(BASEC)
- Newly diagnosed and histologically confirmed solitary atypical meningioma (WHO grade II) based on the WHO criteria of 2016. - Age >/= 18 years. - All anatomical locations are allowed except tumors located in the sheath of the optic nerve. - Complete resection (Simpson 1, 2 or 3), assessed by the surgeon. - Possibility to start radiotherapy treatment within 12 weeks following the surgical intervention. - WHO performance status 0, 1 or 2. - Women of childbearing potential must use an effective contraceptive method throughout the treatment period. - Absence of any psychological, familial, sociological, or geographical circumstances that may compromise adherence to the study protocol and follow-up program; these circumstances must be discussed with the patient before enrollment in the study. - Effective contraceptive method for women of childbearing potential (BASEC)
Exclusion criteria
- Known Neurofibromatosis type II (NF-2). - Tumors of the optic nerve sheath. - Multiple meningiomas. - Radio-induced meningioma. - Clinical evidence of a second malignant tumor, except for cervical carcinoma in situ or basal cell carcinoma. History of invasive malignant tumor, unless the tumor was treated with curative intent and the patient has had no disease in the last five years. - Previous intracranial tumor, in the last 10 years, treated with chemotherapy or radiotherapy. - Pregnant or breastfeeding women. - Persons unable to consent to participate. (BASEC)
Trial sites
Basel, Geneva, Lausanne, Zurich
(BASEC)
Sponsor
SAKK
(BASEC)
Contact
Contact Person Switzerland
Andratschke Nicolaus
+41 442559078
nicolaus.andratschke@clutterusz.chUniversitaetsSpital Zurich
(BASEC)
Scientific Information
(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
16.01.2018
(BASEC)
ICTRP Trial ID
ISRCTN71502099 (ICTRP)
Official title (approved by ethics committee)
Radiation versus Observation following surgical resection of Atypical Meningioma: a randomised controlled trial (The ROAM trial) (BASEC)
Academic title
Radiation versus Observation following surgical resection of Atypical Meningioma: a randomised controlled trial (the ROAM trial) (ICTRP)
Public title
Radiation versus observation following surgical resection of atypical meningioma (ICTRP)
Disease under investigation
Atypical meningioma
Cancer
Benign neoplasm of meninges
(ICTRP)
Intervention under investigation
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 (comparator). Web-based randomisation will be used in this trial. Patients will be followed up for 60 months post randomisation by collecting information on signs/symptoms of tumour recurrence, 6 monthly MRI, recording of adverse events, quality of life questionnaires and cognitive function tests.
(ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Two-arm multi-centre randomised controlled trial (Treatment) (ICTRP)
Inclusion/Exclusion 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
(ICTRP)
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
Primary and secondary end points
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.
(ICTRP)
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.
(ICTRP)
Registration date
19.05.2014 (ICTRP)
Incorporation of the first participant
28.04.2016 (ICTRP)
Secondary sponsors
not available
Additional contacts
Stephanie Willshaw, roam@liverpool.ac.uk, +44 (0)151 794 9766 (ICTRP)
Secondary trial IDs
HTA 12/173/14 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://trialsearch.who.int/Trial2.aspx?TrialID=ISRCTN71502099 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available