Radiation Therapy in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Grade II or Grade III Meningioma

Phase 2

• Conditions: Brain and Central Nervous System Tumors

• Registration Number: NCT00626730
• 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. Giving high-dose radiation therapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying radiation therapy to see how well it works in treating patients who have undergone surgery for newly diagnosed grade II or grade III meningioma.

Detailed Description

OBJECTIVES:

Primary

* To assess the impact of high-dose radiotherapy (RT) on progression-free survival (PFS), treatment tolerance, and post-treatment global cognitive functioning in patients with atypical (WHO grade II) or malignant ( WHO grade III) meningioma.

OUTLINE: Patients with grade II disease are stratified according to resection status (complete excision \[Simpson's stages 1-3\] vs incomplete excision \[Simpson's stages 4-5\]) and participate in a phase II study. These patients are assigned to 1 of 2 treatment groups according to Simpson staging. Only data from these patients is analyzed with respect to the progression-free survival endpoint. Patients with grade III disease are treated in group 1 or 2 according to Simpson staging (as patients with grade II disease). After treatment, the clinical results from these patients are observed and described.

* Group 1 (Simpson stage 1-3): Beginning no later than 6 weeks following surgery, patients undergo radiotherapy once daily, 5 days a week for 6 weeks.

* Group 2 (Simpson stage 4-5): Beginning no later than 6 weeks following surgery, patients undergo radiotherapy once daily, 5 days a week for 7 weeks.

Patients complete a Mini-Mental Status Exam at baseline and at 6 weeks and 6 months after completion of study.

After completion of study treatment, patients are followed at 6 weeks, at 6 and 12 months, and then annually for at least 3 years.

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2008-02-28
• Study First Submitted QC: 2008-02-28
• Study First Posted: 2008-02-29
• Primary Completion: 2013-02
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-02
• Last Update Posted: 2021-02-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 78

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
Mini-mental status exam
Adverse events as assessed by NCI CTCAE v3.0
Overall survival

Trial Locations

Locations (1)

Hopital Cantonal Universitaire de Geneve; 🇨🇭 Geneva, Switzerland