Radiation Therapy in Treating Patients Who Have Undergone Surgery for Newly Diagnosed Grade II or Grade III Meningioma
|ClinicalTrials.gov Identifier: NCT00626730|
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : July 18, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors||Procedure: adjuvant therapy Radiation: radiation therapy||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Official Title:||Adjuvant Postoperative High-Dose Radiotherapy for Atypical and Malignant Meningioma: a Phase-II and Observation Study|
|Study Start Date :||December 2007|
|Primary Completion Date :||February 2013|
- Progression-free survival
- Adverse events as assessed by NCI CTCAE v3.0
- Mini-mental status exam
- Overall survival
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00626730
|Hopital Cantonal Universitaire de Geneve|
|Geneva, Switzerland, CH-1211|
|Study Chair:||Damien C. Weber, MD, PhD||Hopital Cantonal Universitaire de Geneve|