Medical and Surgical Management of Patients With Brain Metastases

NCT ID: NCT03981016

Last Updated: 2020-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-02

Study Completion Date

2020-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Central Nervous System Tumor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Biological collection

For the patients include in the study :

* 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

Group Type EXPERIMENTAL

Biological collection

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Biological collection

* 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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Institut du Cancer de Montpellier - Val d'Aurelle

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Luc Bauchet, MD

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier de Montpellier

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre hospitalier régional et universitaire de Nîmes

Nîmes, Gard, France

Site Status

Centre médical Oncogard

Nîmes, Gard, France

Site Status

Clinique les Franciscaines

Nîmes, Gard, France

Site Status

Laboratoire d'anatomo-pathologie de Nîmes

Nîmes, Gard, France

Site Status

Centre médical Oncodoc Béziers

Béziers, Hérault, France

Site Status

Centre d'Anatomie et Cytologie Pathologiques de Grabels

Grabels, Hérault, France

Site Status

Centre hospitalier régional et universitaire de Montpellier

Montpellier, Hérault, France

Site Status

Clinique Clémentville

Montpellier, Hérault, France

Site Status

Clinique du Millénaire

Montpellier, Hérault, France

Site Status

Institut régional du cancer

Montpellier, Hérault, France

Site Status

Centre hospitalier de Perpignan

Perpignan, Pyrénées-orientales, France

Site Status

Clinique Saint-Pierre

Perpignan, Pyrénées-orientales, France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 22898372 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21109143 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19826419 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21041710 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ICM-URC-2014/21

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

SGM-101 in Colorectal Brain Metastases.
NCT04755920 RECRUITING PHASE2
CIRSE Emprint Microwave Ablation Registry
NCT03775980 ACTIVE_NOT_RECRUITING