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| ID | Type | Description | Link |
|---|---|---|---|
| EORTC-22042 | |||
| EORTC-26042 | |||
| 2005-005551-18 | EudraCT Number |
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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
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adjuvant therapy | Procedure | |||
| radiation therapy | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events as assessed by NCI CTCAE v3.0 | ||
| Mini-mental status exam | ||
| Overall survival |
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DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed meningioma, including the following subtypes:
Atypical WHO grade II meningioma greater than or equal to 4 mitosis per high-power field [HPF] or the presence of at least 3 of the following variables:
Malignant WHO grade III meningioma
All locations allowed except for optic nerve sheets tumors
Complete or subtotal resection as assessed by the surgeon after verification with a postoperative MRI and according to Simpson guidelines
No neurofibromatosis type 2 (NF-2)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Damien C. Weber, MD, PhD | Hopital Cantonal Universitaire de Geneve | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Cantonal Universitaire de Geneve | Geneva | CH-1211 | Switzerland |
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| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D008579 | Meningioma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009383 | Neoplasms, Vascular Tissue |
| D008577 | Meningeal Neoplasms |
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| ID | Term |
|---|---|
| D017024 | Chemotherapy, Adjuvant |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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