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

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)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12698107

Enrollment

112

Registered

2015-11-05

Start date

2016-03-01

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant pleural mesothelioma (MPM) Cancer Malignant pleural mesothelioma

Interventions

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 random

Eligibility

Sex/Gender

All

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)	—

Countries

England, Northern Ireland, Scotland, United Kingdom, Wales

Contacts

Public ContactLaura Alexander

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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026