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

September 20, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Kiel, Germany, D-24105
        • University Hospital Schleswig-Holstein - Kiel Campus
  • Netherlands
      • Deventer, Netherlands, 7400 AC
        • Radiotherapeutisch Instituut-(Riso)
      • Rotterdam, Netherlands, 3000 CA
        • University Medical Center Rotterdam at Erasmus Medical Center
  • Switzerland
      • Geneva, Switzerland, CH-1211
        • Hopital Cantonal Universitaire de Geneve

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Progression-free survival

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Collaborators

NCIC Clinical Trials Group

Investigators

  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (ACTUAL)

November 1, 2006

Study Registration Dates

First Submitted

March 3, 2005

First Submitted That Met QC Criteria

March 3, 2005

First Posted (ESTIMATE)

March 4, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

September 24, 2012

Last Update Submitted That Met QC Criteria

September 20, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-26021 -22021
  • EORTC-26021
  • EORTC-22021
  • CAN-NCIC-EORTC-26021

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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