Observation Versus Conventional-Fractionated Radiotherapy or Radiosurgery After Non-radical Surgery for Benign Intracranial Meningiomas: A Phase III Study
18 Years
N/A
Both
Brain and Central Nervous System Tumors
Trial Information
Observation Versus Conventional-Fractionated Radiotherapy or Radiosurgery After Non-radical Surgery for Benign Intracranial Meningiomas: A Phase III Study
OBJECTIVES:
Primary
- 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
- Compare the quality of life of patients treated with these regimens.
- Compare overall survival of patients treated with these regimens.
- Compare the incidence of a second surgery in patients treated with these regimens.
- Compare the incidence of acute and long-term neurotoxicity in patients treated with
these regimens.
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.
PROJECTED ACCRUAL: A total of 478 patients (239 per treatment arm) will be accrued for this
study within 3-4 years.
Inclusion 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
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival
Safety Issue:
No
Principal Investigator
John G. Wolbers, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
University Medical Center Rotterdam at Erasmus Medical Center
Authority:
United States: Federal Government
Study ID:
EORTC-26021 -22021
NCT ID:
NCT00104936
Start Date:
December 2004
Completion Date:
Related Keywords:
- Brain and Central Nervous System Tumors
- adult grade I meningioma
- Meningioma
- Nervous System Neoplasms
- Central Nervous System Neoplasms
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