Evaluation of the Best Treatment in Terms of Quality of Life for Patients Having a Brain Metastasis

Study Overview
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Brief Summary
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Main Goal : evaluation of quality of life for patient having a brain metastasis and allowed to have either surgery and radiosurgery of the surgical site or only hypofractionned radiosurgery on the lesion. second objectives : evaluation of the local control of the disease evaluation of the overall survival interval without progression evaluation of the medico economic performance of each treatment protocol neuro cognitive evaluation at the end of the protocol

Detailed Description
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A patient with a brain metastasis may have the choice between surgery and focal radiosurgery of the surgical site and only hypofractionned radiosurgery on the lesion. No previous study has focused on quality of life regarding these two treatments options.

Official Title
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Evaluation of the Best Treatment in Terms of Quality of Life for Patients Having a Brain Metastasis

Conditions
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Quality of Life, Brain Metastases

Intervention / Treatment
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* Procedure: surgery and focal radiosurgery of the surgical bed


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: eligible for both treatments options OMS status <3 primary cancer with no evolution brain metastasis < 3cm ou giving symtoms patient with informed consent patient affilated to french social security Exclusion Criteria: OMS > 3 More than 3 brain metastasis brain metastasis already treated with hypofractionned radiosurgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomization between surgery and focal radiosurgery of the surgical site and hypofractionned radiosurgery of the tumor
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: surgery and focal radiosurgery of the surgical site<br> | Procedure: surgery and focal radiosurgery of the surgical bed<br>* hypofractionned radiosurgery of the lesion<br>* Other names: hypofractionned radiosurgery of the lesion;|
| Active Comparator: hypofractionned radiosurgery<br> | Procedure: surgery and focal radiosurgery of the surgical bed<br>* hypofractionned radiosurgery of the lesion<br>* Other names: hypofractionned radiosurgery of the lesion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life EORTC QLQ C30 | score European Organisation for Research and Treatment of Cancer Quality Life Quotation C30 | change between baseline and 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local control of the desease |  | baseline up to 24 month | 
| survival without progression |  | 24 month | 
| overall survival |  | 24 month | 
| medico economic evaluation | cost-utility analysis | 24 month | 
| neuro cognitive evaluation | BOSTON NAMING TEST | 12 and 24 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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brain metastasis, best treatment, quality of life, surgery+radiosurgery, hypofractionned radiosurgery