Stereotactic Radiotherapy for Brain Metastases
- Conditions
- Metastasis Brain
- Interventions
- Radiation: stereotactic radiotherapy
- Registration Number
- NCT03286023
- Lead Sponsor
- Centre Francois Baclesse, Luxembourg
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 110
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Stereotactic radiation stereotactic radiotherapy Stereotactic radiation for brain metastases
- Primary Outcome Measures
Name Time Method Evaluation of tumoral response 8 weeks after treatment Evaluation of response using Magnetic resonance imaging (Recist criteria)
- Secondary Outcome Measures
Name Time Method Evaluation of toxicity 1, 3, 6, 9, 12, 15 months after treatment Evaluation of toxicity using CTCAE v4.0
Trial Locations
- Locations (1)
Centre Francois Baclesse
🇱🇺Esch-sur-Alzette, SUD, Luxembourg