Clinical trial NCT03981016: Medical and Surgical Management of Patients With Brain Metastases
Official title: "In Population" Study of Medical and Surgical Management of Patients With Brain Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Nervous System Tumor
Keywords: Nervous
Central
Tumor
System
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2019-06-10
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients who had a histological study of their brain metastases
timeFrame: 24 months
measure: Number of patients who had a neurosurgery of their brain metastases
timeFrame: 24 months
measure: Number of patients who had a radiotherapy of their brain metastases
timeFrame: 24 months
measure: Number of patients who had a chemotherapy of their brain metastases
timeFrame: 24 months
Secondary outcomes:
measure: Quality of life by using the quality of life questionnaire core (QLQ-C30).
timeFrame: 24 months
measure: Quality of life by using the quality of life questionnaire - brain neoplasm (BN20)
timeFrame: 24 months
measure: Cognitive and neuropsychological functions by using Montreal Cognitive assessment (MoCA)
timeFrame: 24 months
measure: Overall Survival
timeFrame: Approximately 48 months
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Centre hospitalier régional et universitaire de Nîmes
state: Gard
city: Nîmes
country: France
facility: Centre médical Oncogard
state: Gard
city: Nîmes
country: France
facility: Clinique les Franciscaines
state: Gard
city: Nîmes
country: France
facility: Laboratoire d'anatomo-pathologie de Nîmes
state: Gard
city: Béziers
country: France
facility: Centre médical Oncodoc Béziers
state: Hérault
city: Grabels
country: France
facility: Centre d'Anatomie et Cytologie Pathologiques de Grabels
state: Hérault
city: Montpellier
country: France
facility: Centre hospitalier régional et universitaire de Montpellier
state: Hérault
city: Montpellier
country: France
facility: Clinique Clémentville
state: Hérault
city: Montpellier
country: France
facility: Clinique du Millénaire
state: Hérault
city: Montpellier
country: France
facility: Institut régional du cancer
state: Hérault
city: Perpignan
country: France
facility: Centre hospitalier de Perpignan
state: Pyrénées-orientales
city: Perpignan
country: France
facility: Clinique Saint-Pierre
state: Pyrénées-orientales
Study officials:
affiliation: Centre hospitalier de Montpellier
name: Luc Bauchet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davis FG, Dolecek TA, McCarthy BJ, Villano JL. Toward determining the lifetime occurrence of metastatic brain tumors estimated from 2007 United States cancer incidence data. Neuro Oncol. 2012 Sep;14(9):1171-7. doi: 10.1093/neuonc/nos152. Epub 2012 Aug 16.
citation: Fox BD, Cheung VJ, Patel AJ, Suki D, Rao G. Epidemiology of metastatic brain tumors. Neurosurg Clin N Am. 2011 Jan;22(1):1-6, v. doi: 10.1016/j.nec.2010.08.007.
citation: Smedby KE, Brandt L, Backlund ML, Blomqvist P. Brain metastases admissions in Sweden between 1987 and 2006. Br J Cancer. 2009 Dec 1;101(11):1919-24. doi: 10.1038/sj.bjc.6605373. Epub 2009 Oct 13.
citation: Kocher M, Soffietti R, Abacioglu U, Villa S, Fauchon F, Baumert BG, Fariselli L, Tzuk-Shina T, Kortmann RD, Carrie C, Ben Hassel M, Kouri M, Valeinis E, van den Berge D, Collette S, Collette L, Mueller RP. Adjuvant whole-brain radiotherapy versus observation after radiosurgery or surgical resection of one to three cerebral metastases: results of the EORTC 22952-26001 study. J Clin Oncol. 2011 Jan 10;29(2):134-41. doi: 10.1200/JCO.2010.30.1655. Epub 2010 Nov 1.