SYmptom Study of radioThErapy in MeSothelioma
| ISRCTN | ISRCTN10644347 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10644347 |
| Protocol serial number | SYSTEMS2012 |
| Sponsor | NHS Greater Glasgow and Clyde (UK) |
| Funders | June Hancock Mesothelioma Research Fund (UK), Bestson Oncology Fund (UK) |
- 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
Plain English summary of protocol
Contact information
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 |
|---|---|
| barry.laird@ed.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-arm phase II observational study |
| Secondary study design | Other |
| Study type | Participant 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(s) |
This research will assess if radiotherapy is beneficial in treating pain in malignant pleural mesothelioma (MPM). |
| Key secondary outcome measure(s) |
1. To assess whether radiotherapy improves other symptoms (dyspnoea, fatigue, distress) using a number of validated questionnaires |
| Completion date | 15/12/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- Scotland
Study participating centre
EH4 2XR
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| 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.
