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

Caen University Hospital

Status: Unknown

Conditions: Brain Metastases; Quality of Life

Treatments: Procedure: surgery and focal radiosurgery of the surgical bed

Study type: Interventional

Funder types: Other

Identifiers

NCT04358666

19-086

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

surgery and focal radiosurgery of the surgical site

Active Comparator group

Treatment:

Procedure: surgery and focal radiosurgery of the surgical bed

hypofractionned radiosurgery

Active Comparator group

Treatment:

Procedure: surgery and focal radiosurgery of the surgical bed