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

Primary Purpose

Quality of Life, Brain Metastases

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
surgery and focal radiosurgery of the surgical bed
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Quality of Life focused on measuring brain metastasis, best treatment, quality of life, surgery+radiosurgery, hypofractionned radiosurgery

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU CAENRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

surgery and focal radiosurgery of the surgical site

hypofractionned radiosurgery

Arm Description

Outcomes

Primary Outcome Measures

quality of life EORTC QLQ C30
score European Organisation for Research and Treatment of Cancer Quality Life Quotation C30

Secondary Outcome Measures

local control of the desease
survival without progression
overall survival
medico economic evaluation
cost-utility analysis
neuro cognitive evaluation
BOSTON NAMING TEST

Full Information

First Posted
March 31, 2020
Last Updated
April 22, 2020
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT04358666
Brief Title
Evaluation of the Best Treatment in Terms of Quality of Life for Patients Having a Brain Metastasis
Acronym
OPTMETACER
Official Title
Evaluation of the Best Treatment in Terms of Quality of Life for Patients Having a Brain Metastasis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Recruiting
Study Start Date
March 6, 2020 (Actual)
Primary Completion Date
March 30, 2022 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life, Brain Metastases
Keywords
brain metastasis, best treatment, quality of life, surgery+radiosurgery, hypofractionned radiosurgery

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomization between surgery and focal radiosurgery of the surgical site and hypofractionned radiosurgery of the tumor
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
surgery and focal radiosurgery of the surgical site
Arm Type
Active Comparator
Arm Title
hypofractionned radiosurgery
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
surgery and focal radiosurgery of the surgical bed
Other Intervention Name(s)
hypofractionned radiosurgery of the lesion
Intervention Description
hypofractionned radiosurgery of the lesion
Primary Outcome Measure Information:
Title
quality of life EORTC QLQ C30
Description
score European Organisation for Research and Treatment of Cancer Quality Life Quotation C30
Time Frame
change between baseline and 6 month
Secondary Outcome Measure Information:
Title
local control of the desease
Time Frame
baseline up to 24 month
Title
survival without progression
Time Frame
24 month
Title
overall survival
Time Frame
24 month
Title
medico economic evaluation
Description
cost-utility analysis
Time Frame
24 month
Title
neuro cognitive evaluation
Description
BOSTON NAMING TEST
Time Frame
12 and 24 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU CAEN
City
Caen
ZIP/Postal Code
14000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evelyne Emery, MD PhD
Phone
+33 2064605
Email
emery-e@chu-caen.fr
First Name & Middle Initial & Last Name & Degree
jean jacques Dutheil, PhD
Phone
+33 231065351
Email
dutheil-jj@chu-caen.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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