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Stereotactic Radiotherapy for Brain Metastases

Stereotactic Radiotherapy for Patients With Brain Metastases

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03286023
Acronym
CKBrainMeta
Enrollment
110
Registered
2017-09-18
Start date
2014-10-31
Completion date
2022-12-31
Last updated
2022-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastasis Brain

Keywords

brain metastases, stereotactic radiation, cyberknife

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.

Interventions

RADIATIONstereotactic radiotherapy

stereotactic radiotherapy for brain metastases

Sponsors

Centre Francois Baclesse, Luxembourg
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of tumoral response4 weeks after treatmentEvaluation of response using Magnetic resonance imaging (Recist criteria)

Secondary

MeasureTime frameDescription
Evaluation of toxicity1, 3, 6, 9, 12, 15 months after treatmentEvaluation of toxicity using CTCAE v4.0

Countries

Luxembourg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026