A Randomised Multi-Stage Phase II/III Trial of Standard first-line therapy (sunitinib or pazopanib) Comparing Temporary Cessation with Allowing continuation, in the treatment of locally advanced and/or metastatic Renal Cancer (the STAR trial)
Kidney cancer patients on standard drug therapy face severe side effects from continuous treatment cycles. The STAR trial tests whether planned drug-free breaks can maintain survival benefits while reducing toxicity and improving quality of life. This matters because sunitinib and pazopanib, while effective at extending life by cutting off tumour blood supply, cause significant toxicity that can force patients to stop treatment or endure debilitating symptoms. No large trial has yet determined whether a tailored, intermittent schedule—where breaks are guided by individual tumour imaging responses—works as well as continuous dosing. If the modified schedule proves equally effective, patients could experience fewer side effects and better day-to-day wellbeing without sacrificing survival. The NHS would also benefit from lower drug costs and reduced management of toxicities, making treatment more cost-effective. The trial has already shown recruitment is feasible, expanding from 16 to 60 centres, and aims to enrol 1,000 participants over 65 months. Results could establish a new standard of care for advanced kidney cancer, balancing efficacy with quality of life.
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Sunitinib (trade name Sutent) and pazopanib (trade name Votrient) are drugs which target the blood supply of tumours and in recent years have become standard first-line treatment for patients with metastatic and/or locally advanced kidney cancer. Sunitinib/pazopanib treatment achieves increased survival, but is associated with significant toxicity. The STAR trial is a randomised controlled trial comparing the standard schedule of sunitinib or pazopanib (given in continuous cycles) to a modified schedule in which sunitinib or pazopanib cycles are given with planned treatment breaks (drug free intervals), tailored to the responses observed by tumour imaging in individual participants. The STAR trial aims to determine if the modified schedule of sunitinib or pazopanib is as effective as the standard schedule in terms of overall survival, whilst yielding benefits to participants in terms of reduced toxicity and improved quality of life, and to the NHS in terms of better cost effectiveness. The primary outcomes to the trial are overall survival and averaged Quality of Life Adjusted Years (QALYs). A QALY is a way of measuring both the quality and the quantity of life gained by a treatment. The initial stages of the trial aimed to recruit 210 patients from 16 NHS study sites to determine whether recruitment is feasible and the modified schedule of sunitinib looks to be effective. These targets were met in the summer of 2014 and the trial is now expanding to around 60 centres. In total 1000 patients will be recruited over a period of 65 months. At trial entry participants will be randomised equally to either receive sunitinib or pazopanib via the standard schedule of cycles every 6 weeks until progression, or to have the modified schedule with planned treatment breaks. Participants will have clinical assessment 6 weekly and CT/MRI scans 12 weekly until there is evidence of significantly worsening disease whilst receiving sunitinib or pazopanib.
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