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NCT04358666 Clinical Trial

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

Quality of Life Clinical Trial

— OPTMETACER  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04358666
Other study ID # 19-086
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 6, 2020
Est. completion date March 30, 2024

Study information
Verified date March 2020
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date March 30, 2024
Est. primary completion date March 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• surgery and focal radiosurgery of the surgical bed
hypofractionned radiosurgery of the lesion

Locations
Country Name City State
France CHU CAEN Caen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

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