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

Not Applicable

• Conditions: Quality of Life; Brain Metastases
• Interventions: Procedure: surgery and focal radiosurgery of the surgical bed

• Registration Number: NCT04358666
• Lead Sponsor: University Hospital, Caen

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.

Study Timeline

• Status Verified: 2020-03
• Study Start: 2020-03-06
• Study First Submitted: 2020-03-31
• Study First Submitted QC: 2020-04-22
• Last Update Submitted: 2020-04-22
• Study First Posted: 2020-04-24
• Last Update Posted: 2020-04-24
• Primary Completion: 2022-03-30
• Study Completion: 2024-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
surgery and focal radiosurgery of the surgical site	surgery and focal radiosurgery of the surgical bed	-
hypofractionned radiosurgery	surgery and focal radiosurgery of the surgical bed	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

CHU CAEN; 🇫🇷 Caen, France