Releasing interim results from a randomised clinical trial: an example from the QUARTZ trial

Abstract

QUARTZ is the first phase III randomised clinical trial of whole brain radiotherapy (WBRT) for patients with inoperable brain metastases from non-small cell lung cancer. It is designed as a non-inferiority trial to assess whether WBRT may be omitted without detriment to the patient’s survival while improving quality of life. QUARTZ opened to recruitment in March 2007 and currently has 76 UK and Australian centres open. Despite universal support of the importance of the question and a number of major initiatives aimed at improving recruitment, by mid-2010 recruitment was slower than targeted and the trial was under threat of closure. It was suggested that one of the reasons for investigators not offering the trial to large numbers of their patients and for patients rejecting randomisation, was the lack of good quality preliminary randomised data to support the trial question. Therefore it was proposed to make the unusual step to release interim results from the trial in order to provide investigators with further information upon which to base trial decisions and discussions.

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