STAR treatment

A major new national clinical trial for patients with kidney cancer is being led by a team at Leeds, and the first patients have already started receiving treatment.

The £2.8 million project - known as STAR* - could be a landmark trial because, if successful, it may have potential applications for other drugs used in treating other tumour types.

Chief Investigator Dr Janet Brown (School of Medicine, Leeds Institute of Molecular Medicine) is leading a multi-disciplinary team from Leeds and other UK centres to run the trial, which is funded by the National Institute of Health Research Health Technology Assessment Programme.

"Kidney cancer is now the sixth leading cause of cancer-related death," says Dr Brown. "Until recently, the options for treatment of advanced disease were very limited, but a new generation of drugs which can target the blood supply for kidney tumours has been developed. The most widely used of these drugs - sunitinib or Sutent - give a significant survival benefit but cause side- effects which impact on a patient's quality of life. In many cases the dose has to be reduced or the patient may even have to stop taking the drug."

STAR will determine if giving sunitinib with planned treatment breaks gives the same benefits as the standard continuous treatment, but with improved quality of life for the patient and with cost benefits to the NHS. The trial will be in two parts; the first will involve 210 patients in 13 UK centres and will check the approach is working and that the trial is recruiting patients in a timely manner. The second part will involve 1,000 patients in 38 UK NHS centres and the whole study will run for over seven years.

Dr Brown says: "If the trial is successful, treatment break strategies could also be more generally applicable to a range of other drugs in other cancers."

The trial is being run by the Leeds Clinical Trials Research Unit, which includes Co-Chief Investigator Dr Fiona Collinson, Professor Julia Brown and Professor Walter Gregory. Other support includes a qualitative research team led by Professor Jenny Hewison (School of Medicine, Leeds Institute of Health Sciences), health economic experts, renal clinicians and patient representatives.

STAR will also enable three sub-studies: one using a specialised form of MRI scanning which could lead to very early prediction of patient response to sunitinib; the second pursuing the same aim but using Contrast Enhanced CT; and the third, looking at validation of renal cancer biomarkers (molecules which can be easily measured in tissue), which will help in future diagnosis of the disease.

*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.