CRUK/07/001: QUARTZ - A phase III multicentre randomised trial to assess dexamethasone +/- whole brain radiotherapy in patients with inoperable brain

Paula Mulvenna
Medical Research Council
01 January 2007 to 31 December 2013
Clinical Trials Awards & Advisory Committee - Late Phase Study
Funding committee - Clinical Trials Awards and Advisory Committe

Cerebral metastases, from any primary, are a devastating occurrence and most patients deteriorate quickly over a matter of weeks. A number of treatment options have been investigated, but for many years, the standard therapy for patients with inoperable brain metastases has remained a combination of steroids and Whole Brain Radiotherapy (WBRT). However, WBRT can be toxic and has not been shown to consistently improve length or quality of survival, particularly for patients with a non-small cell lung cancer primary.
The aim of this trial is to determine whether dexamethasone alone is as effective as dexamethasone plus WBRT in terms of overall quality of survival time for patients with inoperable brain metastases originating from non-small cell lung cancer, when both groups of patients are also receiving optimal supportive care At the time of referral to the oncology centre, the vast majority of patients will be receiving optimal supportive care (OSC) including dexamethasone for symptom relief. Patients will continue to receive this treatment and in addition will be allocated WBRT (20 Gy in 5 consecutive daily fractions) or not. Because these patients have a short survival time, and may not be well enough to be seen in clinic; a nurse will assess all patients via a weekly telephone call.