Metastasis Brain Clinical Trial
— CKBrainMetaOfficial title:
Stereotactic Radiotherapy for Patients With Brain Metastases
| Verified date | June 2022 |
| Source | Centre Francois Baclesse, Luxembourg |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Active, not recruiting |
| Enrollment | 110 |
| Est. completion date | December 2022 |
| Est. primary completion date | October 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Luxembourg | Centre Francois Baclesse | Esch-sur-Alzette | SUD |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Francois Baclesse, Luxembourg |
Luxembourg,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluation of tumoral response | Evaluation of response using Magnetic resonance imaging (Recist criteria) | 4 weeks after treatment | |
| Primary | Evaluation of tumoral response | Evaluation of response using Magnetic resonance imaging (Recist criteria) | 8 weeks after treatment | |
| Secondary | Evaluation of toxicity | Evaluation of toxicity using CTCAE v4.0 | 1, 3, 6, 9, 12, 15 months after treatment |