PRINCE: Prospective, randomised, multicentre trial of first line systemic treatment and radiotherapy in stage IV non-small cell lung cancer

Radiotherapy to the chest is widely used in the treatment of lung cancer. Its use in stage IV non-small cell lung cancer (NSCLC) has evolved worldwide based on local experience, as doctors attempt to ease symptoms, maintain/improve quality of life, and prolong survival, while minimising side effects. Current palliative thoracic radiotherapy practice is still based on dose fractionations that were studied in the 1990s. However, the past 30 years have seen profound changes in the management of advanced lung cancer, resulting in increasing variation in treatment strategies across centres with regards to the use and timing of radiotherapy. There have been no studies addressing this issue and there is an urgent need to update our evidence base. TOURIST is a pragmatic multi-centre phase III platform incorporating randomised controlled trials (RCTs) of thoracic radiotherapy in the treatment of stage IV NSCLC. The TOURIST Platform has been established to run a series of RCTs across a range of situations where palliative radiotherapy will be used in the treatment of stage IV NSCLC. PRINCE is a multicentre, phase III, RCT with clinical and cost effectiveness, process evaluation and translational research. Patients will be randomised (1:1) to control or early high-dose palliative radiotherapy; all trial patients will receive first-line systemic therapy. Radiotherapy will be investigator’s choice of 36Gy/12F or 39Gy/13F and will begin within 84 days of randomisation and between cycles 1 and 4 of systemic therapy.