Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Dr Barry Laird
ORCID ID
Contact details
Institute of Genetics and Molecular Medicine
Edinburgh Cancer Research UK Centre
Western General Hospital
Crewe Road
Edinburgh
EH4 2XR
United Kingdom
+44 (0)131 777 3548
barry.laird@ed.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SYSTEMS2012
Study information
Scientific title
A single arm observational SYmptom Study of radioThErapy in MeSothelioma
Acronym
SYSTEMS
Study hypothesis
The aim of the SYSTEMS study is to assess the effect of radiotherapy on key symptoms in patients with mesothelioma (e.g. pain) using comprehensive and validated symptom assessment measures.
Ethics approval
Not provided at time of registration
Study design
Single-arm phase II observational study
Primary study design
Observational
Secondary study design
Other
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Malignant pleural mesothelioma (MPM)
Intervention
The symptoms will be measured using validated questionnaires at end of radiotherapy treatment (week 1), at week 5 and week 12 (final study visit)
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
This research will assess if radiotherapy is beneficial in treating pain in malignant pleural mesothelioma (MPM).
Secondary outcome measures
1. To assess whether radiotherapy improves other symptoms (dyspnoea, fatigue, distress) using a number of validated questionnaires
2. Possible biomarkers will be examined and the relationship between inflammation and symptoms explored
Overall trial start date
14/06/2012
Overall trial end date
15/12/2013
Reason abandoned
Eligibility
Participant inclusion criteria
1. >/=18 years of age.
2. Histological or multi-disciplinary team (MDT) diagnosis of mesothelioma
3. Able to complete study assessments
3. Life expectancy of at least 3 months based on clinical judgement
4. Due to receive radiotherapy for pain resulting from mesothelioma (defined as index site site of radiotherapy)
5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
6. CT scan within 6 weeks of radiotherapy
7. Worst pain >4/10 (0-10 Visual Analogue Scale) corresponding to the index site
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
42
Participant exclusion criteria
1. Received chemotherapy or radiotherapy in the preceding six weeks that is likely to alter pain at the index site during the duration of the study
2. Planned chemotherapy during the period of the study that is likely to alter pain during the course of the study
3. Psychotic disorders or cognitive impairment
4. Co-existing lung tumours at the time of study entry
5. Pregnant or breastfeeding
Recruitment start date
14/06/2012
Recruitment end date
15/12/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Western General Hospital
Edinburgh
EH4 2XR
United Kingdom
Sponsor information
Organisation
NHS Greater Glasgow and Clyde (UK)
Sponsor details
c/o Nathaniel Brittian
R&D Central Office
Tennent Institute
1st Floor
Western Infirmary General
38 Church Street
Glasgow
G11 6NT
United Kingdom
+44 (0)141 211 8544
nathaniel.brittian@ggc.scot.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
June Hancock Mesothelioma Research Fund (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Bestson Oncology Fund (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25654216
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27117437