Medical and Surgical Management of Patients With Brain Metastases (CEREMET-LR)

"In Population" Study of 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.

Study Overview

• Status: Completed
• Conditions: Central Nervous System Tumor
• Intervention / Treatment: Other: Biological collection

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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Gard
    • Nîmes, Gard, France, 30000
      • Centre hospitalier régional et universitaire de Nîmes
    • Nîmes, Gard, France, 30000
      • Centre Médical ONCOGARD
    • Nîmes, Gard, France, 30000
      • Clinique Les Franciscaines
    • Nîmes, Gard, France, 30000
      • Laboratoire d'anatomo-pathologie de Nîmes
  • Hérault
    • Béziers, Hérault, France, 34000
      • Centre médical Oncodoc Béziers
    • Grabels, Hérault, France, 34000
      • Centre d'Anatomie et Cytologie Pathologiques de Grabels
    • Montpellier, Hérault, France, 34000
      • Centre hospitalier régional et universitaire de Montpellier
    • Montpellier, Hérault, France, 34000
      • Clinique Clémentville
    • Montpellier, Hérault, France, 34000
      • Clinique du Millenaire
    • Montpellier, Hérault, France, 34298
      • Institut Régional du Cancer
  • Pyrénées-orientales
    • Perpignan, Pyrénées-orientales, France, 66000
      • Centre Hospitalier de Perpignan
    • Perpignan, Pyrénées-orientales, France, 66000
      • Clinique Saint-Pierre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients who had a histological study of their brain metastases	24 months
Number of patients who had a neurosurgery of their brain metastases	24 months
Number of patients who had a radiotherapy of their brain metastases	24 months
Number of patients who had a chemotherapy of their brain metastases	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	24 months
Cognitive and neuropsychological functions by using Montreal Cognitive assessment (MoCA)	Performance on the MoCA (Range : 0-30; higher score indicates better performance)	24 months
Overall Survival		Approximately 48 months

Collaborators and Investigators

• Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
• Investigators: Principal Investigator: Luc Bauchet, MD, Centre Hospitalier de Montpellier

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 2, 2015
• Primary Completion (ACTUAL): January 19, 2018
• Study Completion (ACTUAL): August 31, 2020

Study Registration Dates

• First Submitted: June 6, 2019
• First Submitted That Met QC Criteria: June 7, 2019
• First Posted (ACTUAL): June 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 16, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Central; Tumor; Nervous; System
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Brain Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms
• Other Study ID Numbers: ICM-URC-2014/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No