NCT00104936

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.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_3

Geographic Reach
3 countries

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Last Updated

September 24, 2012

Status Verified

September 1, 2012

Enrollment Period

1.9 years

First QC Date

March 3, 2005

Last Update Submit

September 20, 2012

Conditions

Brain and Central Nervous System Tumors

Keywords

adult grade I meningioma

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

Secondary Outcomes (5)

  • Quality of life

  • Overall survival

  • Incidence of a second surgery

  • Acute neurotoxicity

  • Long-term neurotoxicity

Interventions

adjuvant therapyPROCEDURE
radiation therapyRADIATION
stereotactic radiosurgeryRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

University Hospital Schleswig-Holstein - Kiel Campus

Kiel, D-24105, Germany

Location

Radiotherapeutisch Instituut-(Riso)

Deventer, 7400 AC, Netherlands

Location

University Medical Center Rotterdam at Erasmus Medical Center

Rotterdam, 3000 CA, Netherlands

Location

Hopital Cantonal Universitaire de Geneve

Geneva, CH-1211, Switzerland

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms

Interventions

Chemotherapy, AdjuvantRadiotherapyRadiosurgery

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2005

First Posted

March 4, 2005

Study Start

December 1, 2004

Primary Completion

November 1, 2006

Last Updated

September 24, 2012

Record last verified: 2012-09

Locations

DE(1)NL(2)CH(1)