Medical and Surgical Management of Patients With Brain Metastases

Central Nervous System Tumor Clinical Trial

— CEREMET-LR  

Official title:

"In Population" Study of Medical and Surgical Management of Patients With Brain Metastases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03981016
• Other study ID #: ICM-URC-2014/21
• Status: Completed
• Phase: N/A
• Start date: March 2, 2015
• Est. completion date: August 31, 2020

Study information

• Verified date: October 2020
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: August 31, 2020
• Est. primary completion date: January 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Central Nervous System Neoplasms
• Central Nervous System Tumor
• Nervous System Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	Centre médical Oncodoc Béziers	Béziers	Hérault
France	Centre d'Anatomie et Cytologie Pathologiques de Grabels	Grabels	Hérault
France	Centre hospitalier régional et universitaire de Montpellier	Montpellier	Hérault
France	Clinique Clémentville	Montpellier	Hérault
France	Clinique du Millénaire	Montpellier	Hérault
France	Institut régional du cancer	Montpellier	Hérault
France	Centre hospitalier régional et universitaire de Nîmes	Nîmes	Gard
France	Centre médical Oncogard	Nîmes	Gard
France	Clinique les Franciscaines	Nîmes	Gard
France	Laboratoire d'anatomo-pathologie de Nîmes	Nîmes	Gard
France	Centre hospitalier de Perpignan	Perpignan	Pyrénées-orientales
France	Clinique Saint-Pierre	Perpignan	Pyrénées-orientales

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View 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. Review. — View Citation

Kocher M, Soffietti R, Abacioglu U, Villà 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. — View Citation

Smedby KE, Brandt L, Bäcklund 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who had a histological study of their brain metastases		24 months
Primary	Number of patients who had a neurosurgery of their brain metastases		24 months
Primary	Number of patients who had a radiotherapy of their brain metastases		24 months
Primary	Number of patients who had a chemotherapy of their brain metastases		24 months
Secondary	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
Secondary	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
Secondary	Cognitive and neuropsychological functions by using Montreal Cognitive assessment (MoCA)	Performance on the MoCA (Range : 0-30; higher score indicates better performance)	24 months
Secondary	Overall Survival		Approximately 48 months