A phase III multi-centre randomised controlled trial to assess whether optimal supportive care alone (including dexamethasone) is as effective as optimal supportive care (including dexamethasone) plus whole brain radiotherapy in the treatment of patients with inoperable brain metastases from non-small cell lung cancer

ISRCTN ISRCTN13826061
DOI https://doi.org/10.1186/ISRCTN13826061
ClinicalTrials.gov number NCT00403065
Secondary identifying numbers MRC LU24
Submission date
10/08/2006
Registration date
22/09/2006
Last edited
24/03/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

http://www.cancerhelp.org.uk/trials/a-trial-looking-at-the-treatment-of-lung-cancer-which-has-spread-to-the-brain

Contact information

Dr Paula Mulvenna
Scientific

Northern Centre for Cancer Treatment
Newcastle General Hospital
Newcastle upon Tyne
NE4 6BE
United Kingdom

Phone +44 (0)191 213 8469
Email paula.mulvenna@nuth.nhs.uk

Study information

Study designPhase III multi-centre randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleA phase III multi-centre randomised controlled trial to assess whether optimal supportive care alone (including dexamethasone) is as effective as optimal supportive care (including dexamethasone) plus whole brain radiotherapy in the treatment of patients with inoperable brain metastases from non-small cell lung cancer
Study acronymQUARTZ (Quality of Life After Radiotherapy and Steroids)
Study objectivesThat optimal supportive care (including dexamethasone) alone is as effective as optimal supportive care (including dexamethasone) plus whole brain radiotherapy, in terms of patient-assessed quality-adjusted life-years in patients with non-small cell lung cancer (NSCLC) and inoperable brain metastases.
Ethics approval(s)North West Multicentre Research Ethics Committee, 22/09/2006, ref: 06/MRE08/55
Health condition(s) or problem(s) studiedNon-small cell lung cancer with inoperable brain metastases
InterventionOptimal supportive care (OSC, including dexamethasone) alone versus OSC and whole brain radiotherapy (WBRT).
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase III
Drug / device / biological / vaccine name(s)Dexamethasone
Primary outcome measureQuality-adjusted life-years. Follow-up is weekly until 12 weeks, then 4 weekly, until death.
Secondary outcome measures1. Overall survival
2. Karnofsky Performance Status
3. Patient symptoms
Follow-up is weekly until 12 weeks, then 4 weekly, until death.
Overall study start date02/03/2007
Completion date31/05/2015

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants534
Key inclusion criteria1. Histologically or cytologically proven primary NSCLC
2. Computed tomography (CT)/magnetic resonance imaging (MRI) confirming brain metastases
3. Inoperable brain metastases as assessed by a lung cancer Multi-Disciplinary Team (MDT) or patients for whom surgery is deemed inappropriate
4. Clinician and patient uncertain of the role of whole brain radiotherapy (WBRT)
5. Patient able and willing to respond to questions in a weekly telephone assessment
6. Patient able and willing to give informed consent
7. Aged over 18 years
8. Baseline patient assessment form completed
Key exclusion criteriaCurrent exclusion criteria as of 14/01/2014:
1. Clinician and/or patient certain that WBRT will be of benefit
2. Clinician and/or patient certain that WBRT will not be of benefit
3. Previous or current illness, which has not been brought under control and/or is likely to interfere with protocol treatment or comparisons
4. Chemotherapy (last cycle) within 3 weeks prior to randomisation
5. Previous radiotherapy to the brain
6. Surgery for brain metastases within one month prior to randomisation

Previous exclusion criteria:
1. Clinician and/or patient certain that WBRT will be of benefit
2. Clinician and/or patient certain that WBRT will not be of benefit
3. Previous or current illness, which has not been brought under control and/or is likely to interfere with protocol treatment or comparisons
4. Estimated glomerular filtration rate (EGFR) inhibitors within one week prior to randomisation
5. Chemotherapy (last cycle) within one month prior to randomisation
6. Previous radiotherapy to the brain
7. Surgery for brain metastases within one month prior to randomisation
Date of first enrolment02/03/2007
Date of final enrolment31/08/2014

Locations

Countries of recruitment

  • Australia
  • England
  • United Kingdom

Study participating centre

Newcastle General Hospital
Newcastle upon Tyne
NE4 6BE
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research organisation

c/o David Harrop
MRC Centre London
2nd Floor
Stephenson House
158 -160 North Gower Street
London
NW1 2DA
United Kingdom

Phone +44 (0)207 670 4625
Email dsh@ctu.mrc.ac.uk
Website http://www.centre-london.mrc.ac.uk
ROR logo "ROR" https://ror.org/03x94j517

Funders

Funder type

Charity

Cancer Research UK (CRUK) (UK) (ref: C17956/A6414)
Private sector organisation / Other non-profit organizations
Alternative name(s)
CR_UK, Cancer Research UK - London, CRUK
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/03/2013 Yes No
Results article results 22/10/2016 Yes No
Plain English results 24/03/2022 No Yes

Editorial Notes

24/03/2022: Plain English results added.
09/09/2016: Publication reference added.

14/01/2014: the following changes were made to the trial record:
1. The overall trial end date was changed from 31/03/2012 to 31/05/2015.
2. The target number of participants was changed from 1000 to 534.

17/02/2011: the overall trial end date was changed from 31/03/2010 to 31/03/2012.