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Status:

TERMINATED

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

Lead Sponsor:

European Organisation for Research and Treatment of Cancer - EORTC

Collaborating Sponsors:

NCIC Clinical Trials Group

Conditions:

Brain and Central Nervous System Tumors

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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...

Detailed Description

OBJECTIVES: Primary * Compare progression-free survival of patients with newly diagnosed, incompletely resected, benign intracranial grade I meningioma treated with adjuvant conventional fractionate...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    December 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    9 Patients enrolled

    Trial Details

    Trial ID

    NCT00104936

    Start Date

    December 1 2004

    Last Update

    September 24 2012

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    University Hospital Schleswig-Holstein - Kiel Campus

    Kiel, Germany, D-24105

    2

    Radiotherapeutisch Instituut-(Riso)

    Deventer, Netherlands, 7400 AC

    3

    University Medical Center Rotterdam at Erasmus Medical Center

    Rotterdam, Netherlands, 3000 CA

    4

    Hopital Cantonal Universitaire de Geneve

    Geneva, Switzerland, CH-1211