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

Phase 3

Terminated

• Conditions: Brain and Central Nervous System Tumors

• Registration Number: NCT00104936
• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC

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.

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.

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-03-03
• Study First Submitted QC: 2005-03-03
• Study First Posted: 2005-03-04
• Primary Completion: 2006-11
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-20
• Last Update Posted: 2012-09-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival

Secondary Outcome Measures

Name	Time	Method
Quality of life
Overall survival
Incidence of a second surgery
Acute neurotoxicity
Long-term neurotoxicity

Trial Locations

Locations (4)

Radiotherapeutisch Instituut-(Riso); 🇳🇱 Deventer, Netherlands

Hopital Cantonal Universitaire de Geneve; 🇨🇭 Geneva, Switzerland

University Hospital Schleswig-Holstein - Kiel Campus; 🇩🇪 Kiel, Germany

University Medical Center Rotterdam at Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands