SYmptom Study of radioThErapy in MeSothelioma | Not Recruiting
SYmptom Study of radioThErapy in MeSothelioma
SYSTEMS
Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Malignant pleural mesothelioma (MPM)
Dr Barry Laird
+44 (0)131 777 3548
See all trial contact details
Primary Contact Details
Not Recruiting
Recruitment Status
ISRCTN10644347
Primary Trial ID Number
Summary
http://cancerhelp.cancerresearchuk.org/trials/a-study-find-out-radiotherapy-help-control-pain-people-mesothelioma
Research Details
  • 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.
Phase
Not Specified
Study Design
Single arm phase II observational study
Study Type
Observational
Intervention

The symtoms 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 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
Publication(s)
Sorry, this information is not available
Result Reports
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Gender
Both
Age Range
Adult
Who Can Participate
Patient
Number of Participants
42
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 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
Trial Location(s)
Edinburgh Cancer Research Centre, The University of Edinburgh
Edinburgh
EH4 2XR
Trial Contact(s)
Primary Trial Contact
Dr Barry Laird
barry.laird@ed.ac.uk
+44 (0)131 777 3548
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
Scientific Title
A single arm observational SYmptom Study of radioThErapy in MeSothelioma
EudraCT Number
Sorry, this information is not available
Funder(s)
  • June Hancock Mesothelioma Research Fund (UK)
  • Bestson Oncology Fund (UK)
Other Study ID Numbers
SYSTEMS2012
Sponsor(s)
NHS Greater Glasgow and Clyde (UK)
Key Dates

Recruitment Start Date

14 Jun 2012

Recruitment End Date

15 Dec 2013

Trial Start Date

14 Jun 2012

Trial End Date

15 Dec 2013

Date Assigned

03 Aug 2012

Last Updated

30 Oct 2012