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| Name | Class |
|---|---|
| German Cancer Research Center | OTHER |
| Radiation Oncology Working Group of the German Cancer Society | OTHER |
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The trial evaluates the effect of a moderately increased radiation dose in patients with atypical (grade II) and anaplastic (grade III) meningioma after incomplete or no surgery. Endpoint is recurrence-free survival after 5 years.
The trial intends to optimize treatment for grade II and grade III (atypical or anaplastic) meningioma. Standard treatment for atypical or anaplastic meningioma is surgery. For grade III (anaplastic) meningiomas, post-operative radiotherapy would be performed in all cases using standard fractionation schedules to a total dose of ~60 Gy. For grade II (atypical) meningiomas, although some small patient datasets support early onset of radiotherapy, the standard treatment is still to irradiate if tumours are recurrent or if resection was macroscopically incomplete. Total doses of 54 to ~60 Gy are applied using standard fractionation schedules.
A major problem of the treatment of atypical or anaplastic meningioma is that beyond surgery and radiotherapy, there are only experimental treatment options and the probability of local recurrences is 50-100% within the first 5 years for grade II and grade III meningioma.
The present trial has been developed to evaluate efficacy of a dose-intensified radiotherapy treatment schedule for incompletely or not resected meningioma to a total dose of 68 (grade II) or 72 Gy (grade III). To minimize normal tissue toxicity, the boost dose or the complete radiotherapy is applied using protons. The expectation is a higher recurrence-free survival compared to previous reports on outcome of standard dose (60 Gy) radiotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Grade II tumors (macroscopic) | Experimental | Radiotherapy 68 Gy(RBE) |
|
| Grade III tumors (macroscopic) | Experimental | Radiotherapy 72 Gy(RBE) |
|
| Grade II/III tumors (completely resected) | Active Comparator | Radiotherapy 60 Gy(RBE) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiotherapy 68 Gy(RBE) | Radiation | Radiotherapy 2.0 to 50 Gy(RBE) photon or proton and boost 2 to 18 Gy(RBE) proton |
|
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | 5 years after start of radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| late toxicity | CTC-AE 4.0 | 5 years after start of radiotherapy |
| acute toxicity | CTC-AE 4.0 | 5 years after start of radiotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mechthild Krause, Prof. | Contact | +49 351 458 5441 | mechthild.krause@uniklinikum-dresden.de |
| Name | Affiliation | Role |
|---|---|---|
| Mechthild Krause, Prof. | Technische Universität Dresden, German Cancer Consortium, Helmholtz-Zentrum Dresden - Rossendorf | Study Chair |
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| ID | Term |
|---|---|
| D008579 | Meningioma |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009383 | Neoplasms, Vascular Tissue |
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| Radiotherapy 72 Gy(RBE) | Radiation | Radiotherapy 2.0 to 50 Gy(RBE) photon or proton and boost 2 to 18 Gy(RBE) proton and boost 2 to 4 Gy(RBE) proton |
|
| Radiotherapy 60 Gy(RBE) | Radiation | Radiotherapy 2.0 to 50 Gy(RBE) photon or proton and boost 2 to 10 Gy(RBE) proton |
|
| overall survival | 5 years after start of radiotherapy |
| patterns of recurrence using MRI | 5 years after start of radiotherapy |
| quality of life by validated quality of life questionnaires | EORTC-QLQ-C30, EORTC-QLQ-BN20 | 5 years after start of radiotherapy |
| D008577 | Meningeal Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009422 | Nervous System Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |