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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A01673-46 | Registry Identifier | Ansm |
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the Mask fixation isn't a new solution for the immobilization of the patient's head and has been used in current practice for long years.
This trial is attempting to compare these two technical possibilities of head fixation by mask or by stereotaxic frame. The primary goal is to evaluate the comfort for the patient and specifically for each step of the procedure. It will also evaluate other parameters such as the effectiveness of these two strategies and tolerance.The expected benefit is an improvement of the comfort for the patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group treated by radiosurgery with stereotaxic frame | Active Comparator | Subjects will receive a radiosurgery during a brief hospitalization by LeksellGammaKnifePerfexion® (LGKP) |
|
| Group treated by radiosurgery with the thermoformed mask | Experimental | Subjects will receive a radiosurgery with thermoformed mask during a brief hospitalization by GammaKnifeICON® (GKI) with Efficast® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GammaKnifePerfexion® | Device | neurosurgery |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of pain during the hospitalization (3 days) | Questionary (numeric pain intensity scale) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of tumor control at 3 months | No increase of volume greater than 50% on the MRI | 12 months |
| Evaluation of tumor control at 6 months | No increase of volume greater than 50% on the MRI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| DESALBRES | ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique Hôpitaux de Marseille | Marseille | 13354 | France |
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| GammaKnifeIcon® |
| Device |
neurosurgery |
|
| Efficast® | Device | Thermoformed mask |
|
| MRI | Device |
|
| 12 months |
| Occurrence of clinical side effects | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 12 months |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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