SYSTEMS-2
Research type
Research Study
Full title
SYSTEMS-2 – A Randomised Phase II trial of standard versus dose escalated radiotherapy in the treatment of pain in malignant pleural mesothelioma
IRAS ID
169859
Contact name
Anthony Chalmers
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
ISRCTN Number
ISRCTN12698107
Duration of Study in the UK
2 years, 5 months, 31 days
Research summary
SYSTEMS-2 will investigate whether using a higher dose of radiotherapy will be more beneficial than standard radiotherapy in treating pain caused by mesothelioma.
Pain is one of the most common symptoms experienced by patients with mesothelioma. Unfortunately, conventional painkiller medications are not always effective in controlling this pain and in such cases radiotherapy is often given. Although radiotherapy is often used to treat pain caused by mesothelioma, the best dose and schedule to use is not known.
In an earlier clinical trial we found that standard doses of radiotherapy, 20 Gray delivered over 5 days, can be effective in controlling pain for just under half of patients with mesothelioma. We hope that increasing the dose of radiotherapy will provide better pain control in a higher proportion of patients. New radiotherapy techniques and equipment mean that we can give higher doses without increasing the risks of serious side effects.
Patients previously diagnosed with mesothelioma and referred for radiotherapy for the treatment of pain will be eligible provided they meet the study entry criteria.
The study will be open to recruitment in approximately 12 hospital sites throughout the UK.Eligible patients will be randomised to receive either standard radiotherapy or dose-escalated radiotherapy. After completion of radiotherapy, patients will receive 3 follow-up visits. The maximum trial duration for patients is 26 weeks.
REC name
South East Scotland REC 01
REC reference
15/SS/0225
Date of REC Opinion
19 Jan 2016
REC opinion
Further Information Favourable Opinion