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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00104936
Recruitment Status : Terminated (low accrual)
First Posted : March 4, 2005
Last Update Posted : September 24, 2012
NCIC Clinical Trials Group
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

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.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Procedure: adjuvant therapy Radiation: radiation therapy Radiation: stereotactic radiosurgery Phase 3

Detailed Description:



  • 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.


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Observation Versus Conventional-Fractionated Radiotherapy or Radiosurgery After Non-radical Surgery for Benign Intracranial Meningiomas: A Phase III Study
Study Start Date : December 2004
Primary Completion Date : November 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Progression-free survival

Secondary Outcome Measures :
  1. Quality of life
  2. Overall survival
  3. Incidence of a second surgery
  4. Acute neurotoxicity
  5. Long-term neurotoxicity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • WHO 0-2

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • No serious congestive heart failure


  • 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


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • No prior radiotherapy to the meninges or brain that would preclude study treatment


  • See Disease Characteristics


  • No prior randomization to this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00104936

University Hospital Schleswig-Holstein - Kiel Campus
Kiel, Germany, D-24105
Radiotherapeutisch Instituut-(Riso)
Deventer, Netherlands, 7400 AC
University Medical Center Rotterdam at Erasmus Medical Center
Rotterdam, Netherlands, 3000 CA
Hopital Cantonal Universitaire de Geneve
Geneva, Switzerland, CH-1211
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
NCIC Clinical Trials Group
Study Chair: John G. Wolbers, MD, PhD University Medical Center Rotterdam at Erasmus Medical Center
Study Chair: Raymond Miralbell, MD Hopital Cantonal Universitaire de Geneve
Study Chair: Rolando F. Del Maestro, MD, PhD Montreal Neurological Institute and Hospital
Study Chair: Luis Souhami, MD McGill Cancer Centre at McGill University

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00104936     History of Changes
Other Study ID Numbers: EORTC-26021 -22021
First Posted: March 4, 2005    Key Record Dates
Last Update Posted: September 24, 2012
Last Verified: September 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
adult grade I meningioma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue
Meningeal Neoplasms