Condition category
Cancer
Date applied
19/07/2017
Date assigned
28/07/2017
Last edited
27/07/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 specailised 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 stereotactoc radiotherapy and microsurgery of cerebral metastasis.

Who can participate?
Participants aged 18 to 80 who had their cerebal 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 steteotactic 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 with 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

Contact information

Type

Public

Primary contact

Dr Bogdan Pintea

ORCID ID

Contact details

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

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 stereotactoc 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 steteotactic 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), recrusive partitioning analysis, tumour volume, occurence of hemipareses before and two to three weeks after treatment (surgery or radiaosurgery), 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, Dexamethason daily doses two to threeweeks after treatment, local complications (intracranial bleeding, intracranial abszess, etc.) and systemic complication (pneumonia, sepsis, lung enbolism, etc.).

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

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 Dexamethason/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

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. We identified 68 patients during the target period.

Participant exclusion criteria

Missing clinical data (motoric 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

www.neurochirurgie-Bonn.de

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 is not expected to be made available due to legal concerns. The data was assessed and is held hold at the two clinical site. However if there is 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

Results - basic reporting

Publication summary

Electrophysiologically guided microsurgery of central metastases had a significantly
better functional outcome regarding hemiparesis. However, there was also a trend for less
secondary neurological deterioration after SRT/SRS.

Publication citations

Additional files

Editorial Notes