Comparison of the functional outcome of radiosurgery and microsurgery for the treatment of cerebral metastases

ISRCTN	ISRCTN81776764
DOI	https://doi.org/10.1186/ISRCTN81776764
Secondary identifying numbers	No registration

Submission date: 19/07/2017
Registration date: 28/07/2017
Last edited: 26/11/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Bogdan Pintea
Public

University Hospital Bonn (Universitätskliniken Bonn)
The Clinic and Polyclinic for Neurosurgery (Klinik und Poliklinik für Neurochirurgie)
Sigmund Freud Str. 25
Bonn
53127
Germany

Study information

Study design	Retrospective observational longitudinal study
Primary study design	Observational
Secondary study design	Longitudinal study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	No participant information sheet available
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
Study objectives	The aim of this study is to compare the functional outcome after stereotactic radiotherapy and microsurgery of cerebral metastasis.
Ethics approval(s)	This is a retrospective study of two standard therapies, no personalized data were collected. No consulting is need for retrospective epidemiological studies.
Health condition(s) or problem(s) studied	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
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 study start date	14/05/2014
Completion date	28/02/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Retrospective cohort study with no target recruitment number. 68 patients were identified during the target period.
Total final enrolment	68
Key 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
Key exclusion criteria	Missing clinical data (motor function status, histology, report)
Date of first enrolment	01/06/2014
Date of final enrolment	24/01/2016

Locations

Countries of recruitment

Germany

Study participating centres

Department of Neurosurgery, University Clinics Bonn

Sigmund Freud Str 25
Bonn
53127
Germany

Department of Radiotherapy MediClin Robert Janker Clinic Bonn

Villenstr. 8
Bonn
53129
Germany

Sponsor information

University Hospital Bonn (Universitätskliniken Bonn)
University/education

The Clinic and Polyclinic for Neurosurgery (Klinik und Poliklinik für Neurochirurgie)
Sigmund Freud Str. 25
Bonn
53125
Germany

Website	www.neurochirurgie-Bonn.de
"ROR"	https://ror.org/01xnwqx93

Funders

Funder type

University/education

University Hospital Bonn (Universitätskliniken Bonn)

No information available

Results and Publications

Intention to publish date	30/09/2017
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	The manuscript has been already submitted to the Journal of Radiation Oncology.
IPD sharing plan	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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	13/11/2017	26/11/2020	Yes	No

Editorial Notes

26/11/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
25/10/2017: Internal review.