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NCT Number: NCT03981016

Medical and Surgical Management of Patients With Brain Metastases

The integrated cancer research site (SIRIC) of Montpellier proposes to develop a prospective and regional Clinical Database Project and regional biological collection (blood and tumor samples), which is an expanding data collection designed to contribute to a better understand the patient's management with brain metastases including quality of life and neuropsychological/cognitive aspects.

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Key information

Conditions

Central Nervous System Tumor Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre hospitalier régional et universitaire de Nîmes, Nîmes, Gard, France

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About this study

Brain metastases (BM) represent the first cause of tumors of the central nervous system. Mortality, morbidity (cognitive disorders, neurological deficits, etc.) and their consequences on the quantity and the quality of life are very high. BM represent a real public health problem. The incidence is increasing related to the ageing of the population and the increase of cancer patient's survival rate. The medico-surgical care has highly evolved (neurosurgical progress, radiosurgery, stereotaxic radiotherapy and new chemo and targeted therapy).

Every histological or biological profile requires a specific evaluation, and management. Clinical trials are the reference to establish the efficacy and the toxicity of the new processes, but usually answer only at a single question and for very selected patients.

For this reason, the SIRIC Montpellier Cancer proposes to develop a prospective and regional Clinical Database Project and regional biological collection (blood and tumor samples), which is an expanding data collection designed to contribute to a better understand the patient's management with brain metastases including quality of life and neuropsychological/cognitive aspects.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult ≥ 18 years
  • Radiological diagnosis of brain metastases
  • Patient eligible for neurosurgical exeresis or treatment by radio-surgery
  • Patient treated in a neurosurgery center of the Languedoc-Roussillon region (whatever therapeutic treatment realized on primary tumor)
  • Present brain metastases not previously treated
  • Signed informed consent
  • Patient affiliated to a national insurance system or beneficiary of such a system

Exclusion criteria

  • Patient with primary brain tumor
  • Impossibility to be regularly monitored for psychological, family, social, or geographical reasons
  • Subject under guardianship

Treatment and study plan

Biological collection

Other
  • blood samples collected at different times : Before surgery and during the post-operative visit and
  • frozen tumor samples and / or paraffin samples at the time of surgery and- paraffin around tumor samples at the time of surgery

Primary outcomes

  1. Number of patients who had a histological study of their brain metastases

    Time frame: 24 months

  2. Number of patients who had a neurosurgery of their brain metastases

    Time frame: 24 months

  3. Number of patients who had a radiotherapy of their brain metastases

    Time frame: 24 months

  4. Number of patients who had a chemotherapy of their brain metastases

    Time frame: 24 months

Secondary outcomes

  1. Quality of life by using the quality of life questionnaire core (QLQ-C30).

    Time frame: 24 months

    The EORTC QLQ-C30 uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome.

    The EORTC QLQ-C30 uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. First of all, raw score has to be calculated with mean values. Afterwards linear transformation is performed to be comparable. More points are considered to have a better outcome.

  2. Quality of life by using the quality of life questionnaire - brain neoplasm (BN20)

    Time frame: 24 months

    The QLQ-BN20 questionnaire contains 20 items organized into four scales; future uncertainty (3 items), visual disorder (3 items); motor dysfunction (3 items); and communication deficit (3 items), and seven single items (headaches, seizures, drowsiness, hair loss, itchy skin, weakness of legs, and bladder control). All items are rated on a four-point Likert-type scale ('1=not at all', 2='a little', '3=quite a bit' and '4=very much'), and are linearly transformed to a 0-100 scale, with higher scores indicating more severe symptoms.

  3. Cognitive and neuropsychological functions by using Montreal Cognitive assessment (MoCA)

    Time frame: 24 months

    Performance on the MoCA (Range : 0-30; higher score indicates better performance)

  4. Overall Survival

    Time frame: Approximately 48 months

Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Registry information

Official study title

"In Population" Study of Medical and Surgical Management of Patients With Brain Metastases

Acronym: CEREMET-LR

Important dates

Study start
2015
Primary completion
2018
Study completion
2020
First posted
Jun 10, 2019
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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