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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

This study has been terminated.
(low accrual)
Sponsor:
Collaborator:
NCIC Clinical Trials Group
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00104936
First received: March 3, 2005
Last updated: September 20, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention Phase
Brain and Central Nervous System Tumors
 Procedure: adjuvant therapy
Radiation: radiation therapy
Radiation: stereotactic radiosurgery
 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Primary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Incidence of a second surgery [ Designated as safety issue: No ]
  • Acute neurotoxicity [ Designated as safety issue: Yes ]
  • Long-term neurotoxicity [ Designated as safety issue: Yes ]

Enrollment: 9
Study Start Date: December 2004
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00104936

Locations
Germany
University Hospital Schleswig-Holstein - Kiel Campus
Kiel, Germany, D-24105
Netherlands
Radiotherapeutisch Instituut-(Riso)
Deventer, Netherlands, 7400 AC
University Medical Center Rotterdam at Erasmus Medical Center
Rotterdam, Netherlands, 3000 CA
Switzerland
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
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 Chair: Luis Souhami, MD McGill Cancer Centre at McGill University
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00104936     History of Changes
Other Study ID Numbers: EORTC-26021 -22021, EORTC-26021, EORTC-22021, CAN-NCIC-EORTC-26021
Study First Received: March 3, 2005
Last Updated: September 20, 2012
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on May 19, 2013