Stereotactic Radiotherapy for Brain Metastases

NCT ID: NCT03286023

Last Updated: 2022-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2022-12-31

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.

Detailed Description

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Conditions

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Metastasis Brain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Stereotactic radiation

Stereotactic radiation for brain metastases

stereotactic radiotherapy

Intervention Type RADIATION

stereotactic radiotherapy for brain metastases

Interventions

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stereotactic radiotherapy

stereotactic radiotherapy for brain metastases

Intervention Type RADIATION

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Francois Baclesse, Luxembourg

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Francois Baclesse

Esch-sur-Alzette, SUD, Luxembourg

Site Status

Countries

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Luxembourg

Other Identifiers

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CYM6 Brain metastases CFB 1

Identifier Type: -

Identifier Source: org_study_id

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