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

Sponsors and Collaborators:	European Organization for Research and Treatment of Cancer National Cancer Institute of Canada
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00104936

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 Procedure: radiation therapy Procedure: stereotactic radiosurgery	Phase III

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	Observation Versus Conventional-Fractionated Radiotherapy or Radiosurgery After Non-Radical Surgery for Benign Intracranial Meningiomas: A Phase III Study

Further study details as provided by National Cancer Institute (NCI):

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 ]

Estimated Enrollment:	478
Study Start Date:	December 2004

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 Organization for Research and Treatment of Cancer

National Cancer Institute of Canada

Investigators

Study Chair:	John G. Wolbers, MD, PhD	University Medical Center Rotterdam at Erasmus Medical Center
Investigator:	Raymond Miralbell, MD	Hopital Cantonal Universitaire de Geneve
Study Chair:	Rolando F. Del Maestro, MD, PhD	Montreal Neurological Institute and Hospital
Investigator:	Luis Souhami, MD	McGill Cancer Centre at McGill University

More Information

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

Study ID Numbers:	CDR0000415346, EORTC-26021, EORTC-22021, CAN-NCIC-EORTC-26021
Study First Received:	March 3, 2005
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00104936
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

adult grade I meningioma

Study placed in the following topic categories:

Meningeal Neoplasms
Meningioma
Central Nervous System Neoplasms
Nervous System Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

Nervous System Diseases
Neoplasms, Nerve Tissue
Neoplasms, Vascular Tissue

ClinicalTrials.gov processed this record on January 16, 2009