Stereotactic Radiotherapy for Brain Metastases

Study Overview
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Brief Summary
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Stereotactic radiotherapy is an innovative treatment enabling to target accurately brain metastases. The aim of this study is to evaluate tumoral response and acute and late toxicity of this treatment.

Official Title
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Stereotactic Radiotherapy for Patients With Brain Metastases

Conditions
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Metastasis Brain

Intervention / Treatment
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* Radiation: stereotactic radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Situation 1: in case of several cerebral metastases. In this case, the maximum of cerebral metastases is 3, and the maximum diameter of the largest can not exceed 3 cm. The other two ones can not exceed 1 cm or even maximum 2 cm in diameter for one of the two. The same principle will remain valid in the presence of 2 metastases. Situation 2: in the case of a single metastasis, the diameter should be a maximum of 3 cm Situation 3: in case of metastasis supposed to be radioresistant (renal adenocarcinoma, sarcoma, melanoma ...), only a single metastasis of not more than 3 cm in diameter will be accepted. A primary resection followed by radiotherapy will be preferred. Situation 4: In case of localization near a structure at risk (contact with anterior optical pathways, central nuclei or the brainstem or localization in these structures), a maximum number of 3 metastases may be accepted. However, that included in or close to the risk structure can not exceed 2 cm in diameter and the other two, located outside a risk structure will have a diameter not exceeding 1 or even maximum 2 cm. Situation 5: single metastasis of maximum 3 cm in a context of re-irradiation, the whole encephalon having already received the dose of 10 X 3 Gy or its biological equivalent of dose. Signed informed consent Exclusion Criteria: Impossibility of performing an MRI or a CT-scan of the brain with injection of contrast agent Metastases greater than 3 cm at the start

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stereotactic radiation<br>Stereotactic radiation for brain metastases | Radiation: stereotactic radiotherapy<br>* stereotactic radiotherapy for brain metastases<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of tumoral response | Evaluation of response using Magnetic resonance imaging (Recist criteria) | 4 weeks after treatment | 
| Evaluation of tumoral response | Evaluation of response using Magnetic resonance imaging (Recist criteria) | 8 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of toxicity | Evaluation of toxicity using CTCAE v4.0 | 1, 3, 6, 9, 12, 15 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brain metastases, stereotactic radiation, cyberknife