Radiotherapy or Radiosurgery Compared With Observation Alone in Treating Patients With Newly Diagnosed, Benign Meningioma That Has Been Partially Removed by Surgery

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving radiation therapy or radiosurgery after surgery may kill any remaining tumor cells. It is not yet known whether radiation therapy or radiosurgery is more effective than observation alone in treating benign meningioma. PURPOSE: This randomized phase III trial is studying radiation therapy or radiosurgery to see how well they work compared to observation alone in treating patients with newly diagnosed, benign meningioma that has been partially removed by surgery.

Detailed Description
-----------------
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.

Official Title
-----------------
Observation Versus Conventional-Fractionated Radiotherapy or Radiosurgery After Non-radical Surgery for Benign Intracranial Meningiomas: A Phase III Study

Conditions
-----------------
Brain and Central Nervous System Tumors

Intervention / Treatment
-----------------
* Procedure: adjuvant therapy
* Radiation: radiation therapy
* Radiation: stereotactic radiosurgery


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: adjuvant therapy|nan|
|Radiation: radiation therapy|nan|
|Radiation: stereotactic radiosurgery|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  |  | 
| Overall survival |  |  | 
| Incidence of a second surgery |  |  | 
| Acute neurotoxicity |  |  | 
| Long-term neurotoxicity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adult grade I meningioma