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

Primary Purpose

Central Nervous System Tumor

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biological collection
Sponsored by
Institut du Cancer de Montpellier - Val d'Aurelle
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Central Nervous System Tumor focused on measuring Nervous, Central, Tumor, System

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre hospitalier régional et universitaire de Nîmes
  • Centre médical Oncogard
  • Clinique les Franciscaines
  • Laboratoire d'anatomo-pathologie de Nîmes
  • Centre médical Oncodoc Béziers
  • Centre d'Anatomie et Cytologie Pathologiques de Grabels
  • Centre hospitalier régional et universitaire de Montpellier
  • Clinique Clémentville
  • Clinique du Millénaire
  • Institut régional du cancer
  • Centre hospitalier de Perpignan
  • Clinique Saint-Pierre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Biological collection

Arm Description

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

Outcomes

Primary Outcome Measures

Number of patients who had a histological study of their brain metastases
Number of patients who had a neurosurgery of their brain metastases
Number of patients who had a radiotherapy of their brain metastases
Number of patients who had a chemotherapy of their brain metastases

Secondary Outcome Measures

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.
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.
Cognitive and neuropsychological functions by using Montreal Cognitive assessment (MoCA)
Performance on the MoCA (Range : 0-30; higher score indicates better performance)
Overall Survival

Full Information

First Posted
June 6, 2019
Last Updated
October 16, 2020
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
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1. Study Identification

Unique Protocol Identification Number
NCT03981016
Brief Title
Medical and Surgical Management of Patients With Brain Metastases
Acronym
CEREMET-LR
Official Title
"In Population" Study of Medical and Surgical Management of Patients With Brain Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 2, 2015 (Actual)
Primary Completion Date
January 19, 2018 (Actual)
Study Completion Date
August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Nervous System Tumor
Keywords
Nervous, Central, Tumor, System

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biological collection
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Biological collection
Intervention Description
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 Outcome Measure Information:
Title
Number of patients who had a histological study of their brain metastases
Time Frame
24 months
Title
Number of patients who had a neurosurgery of their brain metastases
Time Frame
24 months
Title
Number of patients who had a radiotherapy of their brain metastases
Time Frame
24 months
Title
Number of patients who had a chemotherapy of their brain metastases
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Quality of life by using the quality of life questionnaire core (QLQ-C30).
Description
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
Title
Quality of life by using the quality of life questionnaire - brain neoplasm (BN20)
Description
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.
Time Frame
24 months
Title
Cognitive and neuropsychological functions by using Montreal Cognitive assessment (MoCA)
Description
Performance on the MoCA (Range : 0-30; higher score indicates better performance)
Time Frame
24 months
Title
Overall Survival
Time Frame
Approximately 48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luc Bauchet, MD
Organizational Affiliation
Centre hospitalier de Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalier régional et universitaire de Nîmes
City
Nîmes
State/Province
Gard
ZIP/Postal Code
30000
Country
France
Facility Name
Centre médical Oncogard
City
Nîmes
State/Province
Gard
ZIP/Postal Code
30000
Country
France
Facility Name
Clinique les Franciscaines
City
Nîmes
State/Province
Gard
ZIP/Postal Code
30000
Country
France
Facility Name
Laboratoire d'anatomo-pathologie de Nîmes
City
Nîmes
State/Province
Gard
ZIP/Postal Code
30000
Country
France
Facility Name
Centre médical Oncodoc Béziers
City
Béziers
State/Province
Hérault
ZIP/Postal Code
34000
Country
France
Facility Name
Centre d'Anatomie et Cytologie Pathologiques de Grabels
City
Grabels
State/Province
Hérault
ZIP/Postal Code
34000
Country
France
Facility Name
Centre hospitalier régional et universitaire de Montpellier
City
Montpellier
State/Province
Hérault
ZIP/Postal Code
34000
Country
France
Facility Name
Clinique Clémentville
City
Montpellier
State/Province
Hérault
ZIP/Postal Code
34000
Country
France
Facility Name
Clinique du Millénaire
City
Montpellier
State/Province
Hérault
ZIP/Postal Code
34000
Country
France
Facility Name
Institut régional du cancer
City
Montpellier
State/Province
Hérault
ZIP/Postal Code
34298
Country
France
Facility Name
Centre hospitalier de Perpignan
City
Perpignan
State/Province
Pyrénées-orientales
ZIP/Postal Code
66000
Country
France
Facility Name
Clinique Saint-Pierre
City
Perpignan
State/Province
Pyrénées-orientales
ZIP/Postal Code
66000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22898372
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.
Results Reference
background
PubMed Identifier
21109143
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.
Results Reference
background
PubMed Identifier
19826419
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.
Results Reference
background
PubMed Identifier
21041710
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.
Results Reference
background

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Medical and Surgical Management of Patients With Brain Metastases

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