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

NCT ID: NCT04358666

Last Updated: 2020-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-06

Study Completion Date

2024-03-30

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.

Conditions

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Quality of Life Brain Metastases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomization between surgery and focal radiosurgery of the surgical site and hypofractionned radiosurgery of the tumor
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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surgery and focal radiosurgery of the surgical site

Group Type ACTIVE_COMPARATOR

surgery and focal radiosurgery of the surgical bed

Intervention Type PROCEDURE

hypofractionned radiosurgery of the lesion

hypofractionned radiosurgery

Group Type ACTIVE_COMPARATOR

surgery and focal radiosurgery of the surgical bed

Intervention Type PROCEDURE

hypofractionned radiosurgery of the lesion

Interventions

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surgery and focal radiosurgery of the surgical bed

hypofractionned radiosurgery of the lesion

Intervention Type PROCEDURE

Other Intervention Names

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hypofractionned radiosurgery of the lesion

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU CAEN

Caen, , France

Site Status RECRUITING

Countries

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France

Facility Contacts

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Evelyne Emery, MD PhD

Role: primary

+33 2064605

jean jacques Dutheil, PhD

Role: backup

+33 231065351

Other Identifiers

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19-086

Identifier Type: -

Identifier Source: org_study_id

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