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Adjuvant Postoperative High-Dose Radiotherapy for Atypical and Malignant Meningioma: a Phase-II and Observation Study
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.
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.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Hopital Cantonal Universitaire de Geneve
Geneva, Switzerland
Start Date
December 1, 2007
Primary Completion Date
February 1, 2013
Last Updated
February 3, 2021
78
ACTUAL participants
adjuvant therapy
PROCEDURE
radiation therapy
RADIATION
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
NCT00602667
NCT00683319
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07416188