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

April 22, 2020 updated by: University Hospital, Caen

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: surgery and focal radiosurgery of the surgical site
Procedure: surgery and focal radiosurgery of the surgical bed
hypofractionned radiosurgery of the lesion
Other Names:
  • hypofractionned radiosurgery of the lesion
Active Comparator: hypofractionned radiosurgery
Procedure: surgery and focal radiosurgery of the surgical bed
hypofractionned radiosurgery of the lesion
Other Names:
  • hypofractionned radiosurgery of the lesion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life EORTC QLQ C30
Time Frame: change between baseline and 6 month
score European Organisation for Research and Treatment of Cancer Quality Life Quotation C30
change between baseline and 6 month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2020

Primary Completion (Anticipated)

March 30, 2022

Study Completion (Anticipated)

March 30, 2024

Study Registration Dates

First Submitted

March 31, 2020

First Submitted That Met QC Criteria

April 22, 2020

First Posted (Actual)

April 24, 2020

Study Record Updates

Last Update Posted (Actual)

April 24, 2020

Last Update Submitted That Met QC Criteria

April 22, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-086

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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