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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04358666
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
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


Condition or disease Intervention/treatment Phase
Quality of Life Brain Metastases Procedure: surgery and focal radiosurgery of the surgical bed Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomization between surgery and focal radiosurgery of the surgical site and hypofractionned radiosurgery of the tumor
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Evaluation of the Best Treatment in Terms of Quality of Life for Patients Having a Brain Metastasis
Actual Study Start Date : March 6, 2020
Estimated Primary Completion Date : March 30, 2022
Estimated Study Completion Date : March 30, 2024

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 Name: hypofractionned radiosurgery of the lesion

Active Comparator: hypofractionned radiosurgery Procedure: surgery and focal radiosurgery of the surgical bed
hypofractionned radiosurgery of the lesion
Other Name: hypofractionned radiosurgery of the lesion




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. local control of the desease [ Time Frame: baseline up to 24 month ]
  2. survival without progression [ Time Frame: 24 month ]
  3. overall survival [ Time Frame: 24 month ]
  4. medico economic evaluation [ Time Frame: 24 month ]
    cost-utility analysis

  5. neuro cognitive evaluation [ Time Frame: 12 and 24 month ]
    BOSTON NAMING TEST



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04358666


Locations
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France
CHU CAEN Recruiting
Caen, France, 14000
Contact: Evelyne Emery, MD PhD    +33 2064605    emery-e@chu-caen.fr   
Contact: jean jacques Dutheil, PhD    +33 231065351    dutheil-jj@chu-caen.fr   
Sponsors and Collaborators
University Hospital, Caen
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Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT04358666    
Other Study ID Numbers: 19-086
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Caen:
brain metastasis, best treatment, quality of life, surgery+radiosurgery, hypofractionned radiosurgery
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases