Condition category
Cancer
Date applied
10/08/2006
Date assigned
22/09/2006
Last edited
09/09/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.centre-london.mrc.ac.uk

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23211715
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27604504

Publication citations

  1. 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.

Additional files

Editorial Notes

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.