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
Contact information
Dr Paula Mulvenna
Scientific
Scientific
Northern Centre for Cancer Treatment
Newcastle General Hospital
Newcastle upon Tyne
NE4 6BE
United Kingdom
| Phone | +44 (0)191 213 8469 |
|---|---|
| paula.mulvenna@nuth.nhs.uk |
Study information
| Study design | Phase III multi-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| 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 |
| Study acronym | QUARTZ (Quality of Life After Radiotherapy and Steroids) |
| Study objectives | 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(s) | North West Multicentre Research Ethics Committee, 22/09/2006, ref: 06/MRE08/55 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | 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 study start date | 02/03/2007 |
| Completion date | 31/05/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 534 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 02/03/2007 |
| Date of final enrolment | 31/08/2014 |
Locations
Countries of recruitment
- Australia
- England
- United Kingdom
Study participating centre
Newcastle General Hospital
Newcastle upon Tyne
NE4 6BE
United Kingdom
NE4 6BE
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research organisation
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 |
|---|---|
| dsh@ctu.mrc.ac.uk | |
| Website | http://www.centre-london.mrc.ac.uk |
"ROR" |
https://ror.org/03x94j517 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK) (ref: C17956/A6414)
Private sector organisation / Other non-profit organizations
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not 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.
