Radiation Therapy in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Grade II or Grade III Meningioma
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.
Brain and Central Nervous System Tumors
Procedure: adjuvant therapy
Radiation: radiation therapy
|Study Design:||Allocation: Non-Randomized
Primary Purpose: Treatment
|Official Title:||Adjuvant Postoperative High-Dose Radiotherapy for Atypical and Malignant Meningioma: a Phase-II and Observation Study|
- Progression-free survival [ Designated as safety issue: No ]
- Adverse events as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
- Mini-mental status exam [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
|Study Start Date:||December 2007|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00626730
|Hopital Cantonal Universitaire de Geneve|
|Geneva, Switzerland, CH-1211|
|Study Chair:||Damien C. Weber, MD, PhD||Hopital Cantonal Universitaire de Geneve|