Brain Metastases, Quality of Life
Conditions
Keywords
brain metastasis, best treatment, quality of life, surgery+radiosurgery, hypofractionned radiosurgery
Brief summary
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
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.
Interventions
PROCEDUREsurgery and focal radiosurgery of the surgical bed
hypofractionned radiosurgery of the lesion
Sponsors
University Hospital, Caen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Intervention model description
randomization between surgery and focal radiosurgery of the surgical site and hypofractionned radiosurgery of the tumor
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| quality of life EORTC QLQ C30 | change between baseline and 6 month | score European Organisation for Research and Treatment of Cancer Quality Life Quotation C30 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| local control of the desease | baseline up to 24 month | — |
| survival without progression | 24 month | — |
| overall survival | 24 month | — |
| medico economic evaluation | 24 month | cost-utility analysis |
| neuro cognitive evaluation | 12 and 24 month | BOSTON NAMING TEST |
Countries
France
Outcome results
None listed