Brain Metastases, Lung Cancer
Conditions
Brief summary
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.
Interventions
DEVICEGammaKnifePerfexion®
neurosurgery
DEVICEGammaKnifeIcon®
neurosurgery
DEVICEEfficast®
Thermoformed mask
DEVICEMRI
Sponsors
Assistance Publique Hopitaux De Marseille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject bearing of one to five intellectual metastases of lung origin at the time of the indication of the radiosurgery * Subject requiring a radiosurgical treatment with LGK
Exclusion criteria
* Subject having hurts of the brainstem or para-optics * Pregnant women or in feeding period * Subject having received previously a whole brain radiotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of pain during the hospitalization (3 days) | 12 months | Questionary (numeric pain intensity scale) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of tumor control at 3 months | 12 months | No increase of volume greater than 50% on the MRI |
| Evaluation of tumor control at 6 months | 12 months | No increase of volume greater than 50% on the MRI |
| Occurrence of clinical side effects | 12 months | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
Countries
France
Outcome results
None listed