SYSTEMS 2: a randomised phase II trial of standard versus dose escalated radiotherapy in the treatment of pain in malignant pleural mesothelioma

ISRCTN	ISRCTN12698107
DOI	https://doi.org/10.1186/ISRCTN12698107
Secondary identifying numbers	Sponsor ref: GN13ON388

Submission date: 05/11/2015
Registration date: 05/11/2015
Last edited: 30/05/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-of-higher-dose-radiotherapy-to-treat-pain-caused-by-mesothelioma-systems-2

Contact information

Mrs Laura Alexander
Public

Cancer Research UK Clinical Trials Unit (partner in CaCTUS - Cancer Clinical Trials Unit Scotland)
Level 0
The Beatson West of Scotland Cancer Centre
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom

Phone	+44 (0)141 301 7212
Email	laura.alexander@glasgow.ac.uk

Study information

Study design	Multicentre Phase II randomised study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet.
Scientific title	A multicentre phase II randomised dose escalation study comparing two schedules of hypo-fractionated radiotherapy: 36 Gy in 6# over two weeks (treatment arm) and 20 Gy in 5# over one week (standard arm)
Study acronym	SYSTEMS-2
Study objectives	To establish whether dose escalated, hypo-fractionated radiotherapy (36 Gray in 6 fractions) increases the proportion of malignant pleural mesothelioma (MPM) patients experiencing a clinically significant improvement in pain at 5 weeks compared with standard radiotherapy (20 Gray in 5 fractions)
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Malignant pleural mesothelioma (MPM)
Intervention	Patients who are due to receive radiotherapy for the treatment of pain due to MPM will be eligible for the study. Patients will be randomised to one of two arms: 1. Standard Treatment: Patients randomised to receive standard radiotherapy will receive 20 Gray of radiotherapy, which will be given in 5 doses. Patients will receive one treatment per day for one week (Monday to Friday) 2. Dose Escalated Treatment: Patients randomised to receive dose escalated radiotherapy will receive 36 Gray of radiotherapy, which will be given in 6 doses. Patients will receive a dose on alternate days over 2 weeks. For patients with large volume disease or where there is a risk of severe acute toxicity there will be the option of reducing dose to 30 Gy in 5 fractions
Intervention type	Procedure/Surgery
Primary outcome measure	Establish whether dose escalated, hypo-fractionated radiotherapy (36 Gy in 6#) increases the proportion of MPM patients experiencing a clinically significant improvement in pain at 5 weeks compared with standard radiotherapy (20 Gy in 5#)
Secondary outcome measures	Determine the relative effects of dose escalated and standard radiotherapy on: 1. Acute toxicity at weeks 5 and 9 2. Pain response at week 5 and 9 ( BPI) 3. Radiological response at week 9, measured by CT scan reported to modified RECIST 4. Overall survival 5. Quality of life at weeks 5 and 9 (EORTC QLQ-C30)
Overall study start date	01/03/2016
Completion date	31/08/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	112
Key inclusion criteria	1. Histological and/or MDT diagnosis of MPM 2. Performance status 0-2 (ECOG) 3. Predicted life expectancy of >12 weeks 4. CT scan within 8 weeks of radiotherapy 5. Worst Pain ≥4/10 (0-10 Numerical Rating Scale) after optimisation of analgesics 6. Ability to provide written informed consent prior to participating in the trial and any trial related procedures being performed 7. Willingness to comply with scheduled visits, treatment plans and laboratory tests and other study procedures 8. Patients must have a radiotherapy plan compatible with both the standard arm (20 Gy in 5 fractions) and treatment arm (30-36 Gy in 5-6 fractions)
Key exclusion criteria	1. Patients who have received anti-cancer therapy within the 4 weeks prior to study entry that is likely to alter pain at the index site during the duration of the study 2. Patients who are planned to have further anti-cancer therapy within 6 weeks post radiotherapy treatment 3. Psychotic disorders or cognitive impairment 4. Co-existing lung tumours at the time of study entry 5. Pregnant or breastfeeding 6. Patients of child-bearing potential, who are unwilling to use 2 effective methods of contraception
Date of first enrolment	01/03/2016
Date of final enrolment	31/08/2018

Locations

Countries of recruitment

England
Northern Ireland
Scotland
United Kingdom
Wales

Study participating centres

Beatson West of Scotland Cancer Centre

1053 Great Western Road
Glasgow
G12 0YN
United Kingdom

The Royal Marsden Hospital

London
SW3 6JJ
United Kingdom

Nottingham City Hospital

Nottingham
NG5 1PB
United Kingdom

Weston Park Hospital

Sheffield
S10 2SJ
United Kingdom

Plymouth Oncology Centre

Plymouth
PL6 8DH
United Kingdom

Velindre Cancer Centre

Velindre
CF14 2TL
United Kingdom

Christie NHS Foundation Trust

Manchester
M20 4BX
United Kingdom

Belfast City Hospital

Belfast
BT9 7AB
United Kingdom

Addenbrookes Hospital

Cambridge
CB2 0QQ
United Kingdom

Southampton General Hospital

Southampton
SO16 6YD
United Kingdom

Royal Preston Hospital

Preston
PR2 9HT
United Kingdom

St. James's Institute of Oncology

Leeds
LS9 7BE
United Kingdom

Sponsor information

NHS Greater Glasgow and Clyde
Hospital/treatment centre

Research and Development Central Office
The Tennent Institute, 1st Floor
Western Infirmary General
38 Church Street
Glasgow
G11 6NT
Scotland
United Kingdom

Website	http://www.nhsggc.org.uk/
"ROR"	https://ror.org/05kdz4d87

University of Glasgow
University/education

Clinical Trials Unit
1st Floor
Tennent Building
38 Church Street
Western Infirmary
Glasgow
G11 6NT
Scotland
United Kingdom

Website	http://www.gla.ac.uk/
"ROR"	https://ror.org/00vtgdb53

Funders

Funder type

Charity

June Hancock Mesothelioma Research Fund
Private sector organisation / Other non-profit organizations

Alternative name(s): JHMRF
Location: United Kingdom

Beatson Cancer Charity
Private sector organisation / Other non-profit organizations

Location: United Kingdom

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
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Plain English results			30/05/2025	No	Yes

Editorial Notes

30/05/2025: Cancer Research UK plain English results link added.
26/10/2016: Cancer Help UK lay summary link added.