Plain English Summary
Background and study aims
Cerebral metastases (cancer cells that have spread to the brain from tumours from other organs in the body) are an upcoming challenge for the oncological (cancer) community as the life expectancy of brain cancer patients improves and, as a consequence, the possibility of cerebral metastasis increases. Moreover, neurological integrity and functional status is becoming an important outcome parameter, as brain cancer develops into a more chronic disease. The main brain metastases treatment are microsurgical resection (a treatment technique that removes the cancer cells using specialised instruments that work on a tiny area) or different radiotherapy modalities (a type of therapy that uses high energy rays like x-rays to destroy cancer cells). Each type of treatment has different advantages as both try to keep the area as intact as possible and keep the function of the brain and protect the region of the brain that is not affected by cancer cells. However, there have been no comparisons of the two methods so far. The aim of this study is to compare the functional outcome after stereotactic radiotherapy and microsurgery of cerebral metastasis.
Who can participate?
Participants aged 18 to 80 who had their cerebral metastasis treated with one of the two types of treatment in January 2008 to September 2009.
What does the study involve?
This is a retrospective chart study that reviewed the surgical outcomes of patients who had either a stereotactic radiotherapy or microsurgery because of a cerebral metastasis located in the motor cortex. Data about their age, tumours, muscle strength, medication and complications are collected.
Outcomes from each type of treatment are compared.
What are the possible benefits and risks of participating?
There are no direct benefits or risks of participating.
Where is the study run from?
1. Department of Neurosurgery, University Clinics Bonn (Germany)
2. Department of Radiotherapy MediClin Robert Janker Clinic Bonn (Germany)
When is the study starting and how long is it expected to run for?
May 2014 to February 2016
Who is funding the study?
University Hospital Bonn (Universitätskliniken Bonn) (Germany)
Who is the main contact?
Dr Bogdan Pintea
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
No registration
Study information
Scientific title
Early motor function after local treatment of brain metastases in the motor cortex region with stereotactic radiotherapy/radiosurgery or microsurgical resection: a retrospective study of two consecutive cohorts
Acronym
Study hypothesis
The aim of this study is to compare the functional outcome after stereotactic radiotherapy and microsurgery of cerebral metastasis.
Ethics approval
This is a retrospective study of two standard therapies, no personalized data were collected. No consulting is need for retrospective epidemiological studies.
Study design
Retrospective observational longitudinal study
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
No participant information sheet available
Condition
Cerebral metastasis
Intervention
This is a retrospective chart review study that looks at the functional outcome of patients either with stereotactic radiotherapy or microsurgery because of a cerebral metastasis located in the motor cortex
The data that is collected from the charts include age, Karnofski performance index (KPI index), recursive partitioning analysis, tumour volume, occurrence of hemipareses before and two to three weeks after treatment (surgery or radiosurgery), muscle strength (conforming to the British Medical Research Council (BMRC) in arm and leg before and two to three weeks after the treatment they received, histology, Dexamethasone daily doses two to three weeks after treatment, local complications (intracranial bleeding, intracranial abscess, etc.) and systemic complication (pneumonia, sepsis, lung embolism, etc.).
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Motoric function/hemiparesis is assessed by reviewing the patients notes and reports bevor treatment and three to four weeks after treatment
Secondary outcome measures
1. Need of dexamethasone/antioedema therapy are assessed by reviewing the patients notes and reports three to four weeks after treatment
2. Systemic and local complications were assessed by reviewing the patients notes and reports three to four weeks after treatment
Overall trial start date
14/05/2014
Overall trial end date
28/02/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with cerebral metastasis treated either with stereotactic radiotherapy or microsurgery during the period 01/2008 to 09/2012
2. Aged 18 to 80 years old
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Retrospective cohort study with no target recruitment number. 68 patients were identified during the target period.
Participant exclusion criteria
Missing clinical data (motor function status, histology, report)
Recruitment start date
01/06/2014
Recruitment end date
24/01/2016
Locations
Countries of recruitment
Germany
Trial participating centre
Department of Neurosurgery, University Clinics Bonn
Sigmund Freud Str 25
Bonn
53127
Germany
Trial participating centre
Department of Radiotherapy MediClin Robert Janker Clinic Bonn
Villenstr. 8
Bonn
53129
Germany
Sponsor information
Organisation
University Hospital Bonn (Universitätskliniken Bonn)
Sponsor details
The Clinic and Polyclinic for Neurosurgery (Klinik und Poliklinik für Neurochirurgie)
Sigmund Freud Str. 25
Bonn
53125
Germany
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University Hospital Bonn (Universitätskliniken Bonn)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The manuscript has been already submitted to the Journal of Radiation Oncology.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to legal concerns. The data was assessed and is held at the two clinical sites. However, if there is a defined request the local ethics committee can be asked for dataset release.
Intention to publish date
30/09/2017
Participant level data
Not expected to be available
Basic results (scientific)
Publication list