Condition category
Cancer
Date applied
05/11/2015
Date assigned
05/11/2015
Last edited
26/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Public

Primary contact

Mrs Laura Alexander

ORCID ID

Contact details

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
0141 301 7212
laura.alexander@glasgow.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Sponsor ref: GN13ON388

Study information

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)

Acronym

SYSTEMS-2

Study hypothesis

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

Not provided at time of registration

Study design

Multicentre phase II randomised study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/03/2016

Overall trial end date

31/08/2018

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

112

Participant 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

Recruitment start date

01/03/2016

Recruitment end date

31/08/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Beatson West of Scotland Cancer Centre
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom

Trial participating centre

The Royal Marsden Hospital
London
SW3 6JJ
United Kingdom

Trial participating centre

Nottingham City Hospital
Nottingham
NG5 1PB
United Kingdom

Trial participating centre

Weston Park Hospital
Sheffield
S10 2SJ
United Kingdom

Trial participating centre

Plymouth Oncology Centre
Plymouth
PL6 8DH
United Kingdom

Trial participating centre

Velindre Cancer Centre
Velindre
CF14 2TL
United Kingdom

Trial participating centre

Christie NHS Foundation Trust
Manchester
M20 4BX
United Kingdom

Trial participating centre

Belfast City Hospital
Belfast
BT9 7AB
United Kingdom

Trial participating centre

Addenbrookes Hospital
Cambridge
CB2 0QQ
United Kingdom

Trial participating centre

Southampton General Hospital
Southampton
SO16 6YD
United Kingdom

Trial participating centre

Royal Preston Hospital
Preston
PR2 9HT
United Kingdom

Trial participating centre

St. James's Institute of Oncology
Leeds
LS9 7BE
United Kingdom

Sponsor information

Organisation

NHS Greater Glasgow & Clyde

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Organisation

University of Glasgow

Sponsor details

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

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

June Hancock Mesothelioma Research Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Beatson Cancer Charity

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

26/10/2016: Cancer Help UK lay summary link added.