Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Dr Paula Mulvenna
ORCID ID
Contact details
Northern Centre for Cancer Treatment
Newcastle General Hospital
Newcastle upon Tyne
NE4 6BE
United Kingdom
+44 (0)191 213 8469
paula.mulvenna@nuth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00403065
Protocol/serial number
MRC LU24
Study information
Scientific title
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
Acronym
QUARTZ (Quality of Life After Radiotherapy and Steroids)
Study hypothesis
That 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
North West Multicentre Research Ethics Committee, 22/09/2006, ref: 06/MRE08/55
Study design
Phase III multi-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Non-small cell lung cancer with inoperable brain metastases
Intervention
Optimal supportive care (OSC, including dexamethasone) alone versus OSC and whole brain radiotherapy (WBRT).
Intervention type
Drug
Phase
Phase III
Drug names
Dexamethasone
Primary outcome measure
Quality-adjusted life-years. Follow-up is weekly until 12 weeks, then 4 weekly, until death.
Secondary outcome measures
1. Overall survival
2. Karnofsky Performance Status
3. Patient symptoms
Follow-up is weekly until 12 weeks, then 4 weekly, until death.
Overall trial start date
02/03/2007
Overall trial end date
31/05/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
534
Participant exclusion criteria
Current 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
Recruitment start date
02/03/2007
Recruitment end date
31/08/2014
Locations
Countries of recruitment
Australia, United Kingdom
Trial participating centre
Newcastle General Hospital
Newcastle upon Tyne
NE4 6BE
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
c/o David Harrop
MRC Centre London
2nd Floor
Stephenson House
158 -160 North Gower Street
London
NW1 2DA
United Kingdom
+44 (0)207 670 4625
dsh@ctu.mrc.ac.uk
Sponsor type
Research organisation
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK) (ref: C17956/A6414)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23211715
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27604504
Publication citations
-
Results
Langley RE, Stephens RJ, Nankivell M, Pugh C, Moore B, Navani N, Wilson P, Faivre-Finn C, Barton R, Parmar MK, Mulvenna PM, , Interim data from the Medical Research Council QUARTZ Trial: does whole brain radiotherapy affect the survival and quality of life of patients with brain metastases from non-small cell lung cancer?, Clin Oncol (R Coll Radiol), 2013, 25, 3, e23-30, doi: 10.1016/j.clon.2012.11.002.