Medical and Surgical Management of Patients With Brain Metastases

Institut du Cancer de Montpellier - Val d'Aurelle105 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

105

Conditions

Central Nervous System Tumor

Interventions

Biological collectionOTHER

* 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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adult ≥ 18 years 2. Radiological diagnosis of brain metastases 3. Patient eligible for neurosurgical exeresis or treatment by radio-surgery 4. Patient treated in a neurosurgery center of the Languedoc-Roussillon region (whatever therapeutic treatment realized on primary tumor) 5. Present brain metastases not previously treated 6. Signed informed consent 7. Patient affiliated to a national insurance system or beneficiary of such a system Exclusion Criteria: 1. Patient with primary brain tumor 2. Impossibility to be regularly monitored for psychological, family, social, or geographical reasons 3. Subject under guardianship

Locations (12)

Centre hospitalier régional et universitaire de Nîmes

Nîmes, Gard, France

Centre médical Oncogard

Nîmes, Gard, France

Clinique les Franciscaines

Nîmes, Gard, France

Outcomes

Primary Outcomes

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

Time frame: 24 months

Number of patients who had a neurosurgery of their brain metastases

Time frame: 24 months

Number of patients who had a radiotherapy of their brain metastases

Time frame: 24 months

Number of patients who had a chemotherapy of their brain metastases

Time frame: 24 months

Secondary Outcomes

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

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.

Time frame: 24 months

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

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.

Data from ClinicalTrials.gov

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