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Radiation Therapy in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Grade II or Grade III Meningioma

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: NCT00626730
Recruitment Status : Active, not recruiting
First Posted : February 29, 2008
Last Update Posted : February 3, 2021
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. Giving high-dose radiation therapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying radiation therapy to see how well it works in treating patients who have undergone surgery for newly diagnosed grade II or grade III meningioma.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Procedure: adjuvant therapy Radiation: radiation therapy Phase 2

Detailed Description:



  • To assess the impact of high-dose radiotherapy (RT) on progression-free survival (PFS), treatment tolerance, and post-treatment global cognitive functioning in patients with atypical (WHO grade II) or malignant ( WHO grade III) meningioma.

OUTLINE: Patients with grade II disease are stratified according to resection status (complete excision [Simpson's stages 1-3] vs incomplete excision [Simpson's stages 4-5]) and participate in a phase II study. These patients are assigned to 1 of 2 treatment groups according to Simpson staging. Only data from these patients is analyzed with respect to the progression-free survival endpoint. Patients with grade III disease are treated in group 1 or 2 according to Simpson staging (as patients with grade II disease). After treatment, the clinical results from these patients are observed and described.

  • Group 1 (Simpson stage 1-3): Beginning no later than 6 weeks following surgery, patients undergo radiotherapy once daily, 5 days a week for 6 weeks.
  • Group 2 (Simpson stage 4-5): Beginning no later than 6 weeks following surgery, patients undergo radiotherapy once daily, 5 days a week for 7 weeks.

Patients complete a Mini-Mental Status Exam at baseline and at 6 weeks and 6 months after completion of study.

After completion of study treatment, patients are followed at 6 weeks, at 6 and 12 months, and then annually for at least 3 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: Adjuvant Postoperative High-Dose Radiotherapy for Atypical and Malignant Meningioma: a Phase-II and Observation Study
Actual Study Start Date : December 2007
Actual Primary Completion Date : February 2013

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Progression-free survival

Secondary Outcome Measures :
  1. Adverse events as assessed by NCI CTCAE v3.0
  2. Mini-mental status exam
  3. Overall survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed newly diagnosed meningioma, including the following subtypes:

    • Atypical WHO grade II meningioma greater than or equal to 4 mitosis per high-power field [HPF] or the presence of at least 3 of the following variables:

      • Cellularity
      • Architectural sheeting (i.e., patternless pattern)
      • Macronuclei cell formation
      • Small cell formation
    • Malignant WHO grade III meningioma
  • All locations allowed except for optic nerve sheets tumors
  • Complete or subtotal resection as assessed by the surgeon after verification with a postoperative MRI and according to Simpson guidelines
  • No neurofibromatosis type 2 (NF-2)


  • WHO performance status 0-2
  • Not pregnant or nursing
  • Fertile patients must use effective contraception during study therapy
  • May be registered on this trial only once
  • No clinical evidence of second malignancies except carcinoma in situ of the cervix or basocellular carcinoma
  • No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule


  • No prior radiotherapy to the brain or meninges interfering with the protocol treatment plan

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): NCT00626730

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Hopital Cantonal Universitaire de Geneve
Geneva, Switzerland, CH-1211
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
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Study Chair: Damien C. Weber, MD, PhD Hopital Cantonal Universitaire de Geneve
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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00626730    
Other Study ID Numbers: EORTC-22042-26042
2005-005551-18 ( EudraCT Number )
First Posted: February 29, 2008    Key Record Dates
Last Update Posted: February 3, 2021
Last Verified: February 2021
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
adult grade II meningioma
adult grade III meningioma
Additional relevant MeSH terms:
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Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Neoplasms by Site
Nervous System Diseases