Adjuvant Postoperative High-Dose Radiotherapy for Atypical and Malignant Meningioma: a Phase-II and Observation Study
- 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.
Allocation: Non-Randomized, Primary Purpose: Treatment
Damien C. Weber, MD, PhD
Hopital Cantonal Universitaire de Geneve