SYmptom Study of radioThErapy in MeSothelioma

ISRCTN	ISRCTN10644347
DOI	https://doi.org/10.1186/ISRCTN10644347
Secondary identifying numbers	SYSTEMS2012

Submission date: 17/05/2012
Registration date: 03/08/2012
Last edited: 25/01/2022

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

http://cancerhelp.cancerresearchuk.org/trials/a-study-find-out-radiotherapy-help-control-pain-people-mesothelioma

Contact information

Dr Barry Laird
Scientific

Institute of Genetics and Molecular Medicine
Edinburgh Cancer Research UK Centre
Western General Hospital
Crewe Road
Edinburgh
EH4 2XR
United Kingdom

Phone	+44 (0)131 777 3548
Email	barry.laird@ed.ac.uk

Study information

Study design	Single-arm phase II observational study
Primary study design	Observational
Secondary study design	Other
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A single arm observational SYmptom Study of radioThErapy in MeSothelioma
Study acronym	SYSTEMS
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	14/06/2012
Completion date	15/12/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	42
Total final enrolment	40
Key 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
Key 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
Date of first enrolment	14/06/2012
Date of final enrolment	15/12/2013

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

Western General Hospital

Edinburgh
EH4 2XR
United Kingdom

Sponsor information

NHS Greater Glasgow and Clyde (UK)
Hospital/treatment centre

c/o Nathaniel Brittian
R&D Central Office, Tennent Institute, 1st Floor
Western Infirmary General
38 Church Street
Glasgow
G11 6NT
Scotland
United Kingdom

Phone	+44 (0)141 211 8544
Email	nathaniel.brittian@ggc.scot.nhs.uk
"ROR"	https://ror.org/05kdz4d87

Funders

Funder type

Charity

June Hancock Mesothelioma Research Fund (UK)

No information available

Bestson Oncology Fund (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2015		Yes	No
Results article	results	01/11/2016		Yes	No
Plain English results		04/09/2015	25/01/2022	No	Yes

Editorial Notes

25/01/2022: The following changes have been made:
1. The Cancer Research UK lay results summary has been added.
2. The total final enrolment number has been added.
27/04/2016: Publication reference added.
06/04/2016: Publication reference added.