Condition category
Cancer
Date applied
17/05/2012
Date assigned
03/08/2012
Last edited
05/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Publication citations

Additional files

Editorial Notes

27/04/2016: Publication reference added. 06/04/2016: Publication reference added.