Radiotherapy or Radiosurgery Compared With Observation Alone in Treating Patients With Newly Diagnosed, Benign Meningioma That Has Been Partially Removed by Surgery
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.
Brain and Central Nervous System Tumors
Procedure: adjuvant therapy
Radiation: radiation therapy
Radiation: stereotactic radiosurgery
|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|
- Progression-free survival [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||December 2004|
|Primary Completion Date:||November 2006 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00104936
|University Hospital Schleswig-Holstein - Kiel Campus|
|Kiel, Germany, D-24105|
|Deventer, Netherlands, 7400 AC|
|University Medical Center Rotterdam at Erasmus Medical Center|
|Rotterdam, Netherlands, 3000 CA|
|Hopital Cantonal Universitaire de Geneve|
|Geneva, Switzerland, CH-1211|
|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|