Phase III Randomized Study of Adjuvant
Conventional Fractionated Radiotherapy
or Radiosurgery Versus Observation Only
in Patients With Newly Diagnosed,
Incompletely Resected, Benign
Intracranial Grade I Meningioma
Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Projected Accrual
Outline
Trial Contact Information
Alternate Title
Radiotherapy or Radiosurgery Compared With Observation
Alone in Treating Patients With Newly Diagnosed, Benign
Meningioma That Has Been Partially Removed by Surgery
Basic Trial Information
Phase Type
Status Age
Sponsor Protocol IDs
Phase Treatment Active 18 and Other
III
over
Objectives
EORTC-26021
EORTC22021,
NCT00104936,
CAN-NCICEORTC-26021
Primary
1. Compare progression-free survival of patients with newly
diagnosed, incompletely resected, benign intracranial
grade I meningioma treated with adjuvant conventional
fractionated radiotherapy or radiosurgery vs observation
only.
Secondary
1. Compare the quality of life of patients treated with these
regimens.
2. Compare overall survival of patients treated with these
regimens.
3. Compare the incidence of a second surgery in patients
treated with these regimens.
4. Compare the incidence of acute and long-term
neurotoxicity in patients treated with these regimens.
Entry Criteria
Disease Characteristics:

Histologically confirmed newly diagnosed benign
intracranial meningioma

WHO grade I

Any location except orbital meningioma

Mitotic index < 4 (total counts per 10 high-power field)
AND MIB-1 labeling index < 4%

The following histologies are not allowed (i.e., WHO grade
II or III):

Atypical

Clear cell

Choroid

Rhabdoid



Papillary
Anaplastic
Must have undergone non-radical resection* within the
past 7 months

Post-operative MRI (performed 4 months after
surgery) demonstrating stages 3, 4, or 5
[Note: *Biopsy only is considered non-radical resection and
may be classified as stage 4 or 5 according to tumor volume]

No brain invasion

No hemangiopericytoma

No fibrous dysplasia or intra-osseous meningioma

No multiple meningiomas or meningiomatosis

Not part of neurofibromatosis type II
Prior/Concurrent Therapy:
Biologic therapy

Not specified
Chemotherapy

Not specified
Endocrine therapy

Not specified
Radiotherapy

No prior radiotherapy to the meninges or brain that would
preclude study treatment
Surgery

See Disease Characteristics
Other

No prior randomization to this study
Patient Characteristics:
Age

18 and over
Performance status

WHO 0-2
Life expectancy

Not specified
Hematopoietic

Not specified
Hepatic

Not specified
Renal

Not specified
Cardiovascular

No serious congestive heart failure
Other




HIV negative
No other malignancy except basal cell skin cancer or
carcinoma in situ of the cervix
No other disease that would preclude 5-year follow up
after study completion
No psychological, familial, sociological, or geographical
condition that would preclude study compliance or study
follow up
Projected Accrual
A total of 478 patients (239 per treatment arm) will be accrued
for this study within 3-4 years.
Outline
This is a randomized, multicenter study. Patients are stratified
according to post-surgery MRI staging (3 vs 4 vs 5), skull base
location (yes vs no), age (< 60 vs ≥ 60), and participating
center. Patients are randomized to 1 of 2 treatment arms.


Arm I: Patients undergo observation only.
Arm II: Within 4-7 months after surgery, patients undergo
conventional fractionated radiotherapy once daily, 5 days a
week for 6 weeks OR a single treatment of high-dose
radiosurgery in the absence of unacceptable toxicity.
Quality of life is assessed at baseline, at 6 months after
randomization, and then annually thereafter.
After completion of study treatment, patients are followed at 3
and 6 months after randomization and then annually thereafter.
Disclaimer
The purpose of most clinical trials listed in this database is to
test new cancer treatments, or new methods of diagnosing,
screening, or preventing cancer. Because all potentially harmful
side effects are not known before a trial is conducted, dose and
schedule modifications may be required for participants if they
develop side effects from the treatment or test. The therapy or
test described in this clinical trial is intended for use by clinical
oncologists in carefully structured settings, and may not prove
to be more effective than standard treatment. A responsible
investigator associated with this clinical trial should be
consulted before using this protocol.
Trial Contact Information
Trial Lead Organizations
European Organization for Research and Treatment of
Cancer
John Wolbers, MD, PhD, Ph: 31-10-463-2776
Protocol chair
Email:
j.wolbers@erasmusme.nl
Raymond Miralbell, MD,
Protocol co-chair
Ph: 41-22-382-7098
Email:
raymond.miralbell@hcuge.ch
NCIC-Clinical Trials Group
Rolando Del Maestro,
MD, Protocol chair
Ph: 514-398-5791
Email:
rolando.delmaestro@mcgill.ca
Luis Souhami, MD,
Protocol co-chair
Ph: 514-934-8040 ext. 43163
Email:
luis.souhami@muhc.mcgill.ca
Trial Sites and Contacts
HOPITAL UNIVERSITAIRE ERASME (BRUSSELS, Belgium) - Inst. 131
CENTRE ANTOINE LACASSAGNE (NICE, France) - Inst. 218
CHU PITIE-SALPETRIERE (PARIS, France) - Inst. 233
ISTITUTO REGINA ELENA (ROMA, Italy) - Inst. 742
INSTITUT CATALA D'ONCOLOGIA (L'HOSPITALET BARCELONA, Spain) - Inst. 6225
MEDISCH CENTRUM HAAGLANDEN - WESTEINDE (DEN HAAG, The Netherlands) - Inst. 311
ERASMUS MC (ROTTERDAM, The Netherlands) - Inst. 336