biostudies-literatureCollinson FJCancer Research UKNational Institute for Health Research (NIHR)598https://www.ebi.ac.uk/biostudies/studies/S-EPMC3583710biostudies-literatureUnknown12<h4>Background</h4>Over recent years a number of novel therapies have shown promise in advanced renal cell carcinoma (RCC). Internationally the standard of care of first-line therapy is sunitinib™, after a clear survival benefit was demonstrated over interferon-α. Convention dictates that sunitinib is continued until evidence of disease progression, assuming tolerability, although there is no evidence that this approach is superior to intermittent periods of treatment. The purpose of the STAR trial is to compare the standard treatment strategy (conventional continuation strategy, CCS) with a novel drug free interval strategy (DFIS) which includes planned treatment breaks.<h4>Methods/design</h4>The STAR trial is an NIHR HTA-funded UK pragmatic randomised phase II/III clinical trial in the fBMC cancerThe STAR trial protocol: a randomised multi-stage phase II/III study of Sunitinib comparing temporary cessation with allowing continuation, at the time of maximal radiological response, in the first-line treatment of locally advanced/metastatic renal cancer.PMC358371009/91/21HTA/09/91/2110048McParland LWah TMcCabe CHanlon PHoward HLowe CCollinson FJTubeuf SGregory WMSelby PJBrown JPotrata DHewison JfalseThe STAR trial protocol: a randomised multi-stage phase II/III study of Sunitinib comparing temporary cessation with allowing continuation, at the time of maximal radiological response, in the first-line treatment of locally advanced/metastatic renal cancer.<h4>Background</h4>Over recent years a number of novel therapies have shown promise in advanced renal cell carcinoma (RCC). Internationally the standard of care of first-line therapy is sunitinib™, after a clear survival benefit was demonstrated over interferon-α. Convention dictates that sunitinib is continued until evidence of disease progression, assuming tolerability, although there is no evidence that this approach is superior to intermittent periods of treatment. The purpose of the STAR trial is to compare the standard treatment strategy (conventional continuation strategy, CCS) with a novel drug free interval strategy (DFIS) which includes planned treatment breaks.<h4>Methods/design</h4>The STAR trial is an NIHR HTA-funded UK pragmatic randomised phase II/III clinical trial in the f2012-01-01T00:00:00Z2012 Dec2025-04-22T15:39:47.563Z2019-03-27T01:05:22ZS-EPMC35837102324143910.1186/1471-2407-12-598