STAR: Standard vs Modified Drug Therapy in Renal Cancer
Research type
Research Study
Full title
STAR: 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
IRAS ID
75784
Contact name
Janet Elizabeth Brown
Contact email
Sponsor organisation
University of Leeds
Eudract number
2011-001098-16
ISRCTN Number
ISRCTN06473203
Duration of Study in the UK
6 years, 6 months, 0 days
Research summary
Summary of Research
STAR, a randomised controlled trial, compares Standard Schedule therapy (given continuously) to a Modified Schedule(cycles given with drug free intervals between), tailored to the responses observed by tumour imaging in individual
participants. STAR aims to determine if the Modified Schedule is as effective as the Standard Schedule in terms of survival, whilst benefiting participants in terms of reduced toxicity and the NHS in terms of improved cost effectiveness.
The primary outcomes are overall survival and averaged Quality of Life Adjusted Years, a way of measuring the quality and quantity of life gained by a treatment.
All participants receive treatment with either sunitinib or pazopanib, based on their clinician’s preference. Both drugs are tyrosine kinase inhibitors (TKIs) which target the blood supply of tumours, and both are used in first line standard
treatment for metastatic and/or locally advanced kidney cancer.
STAR was originally designed using only sunitinib, with the possibility of including pazopanib at a later date considered in the protocol. After consideration of COMPARZ trial data in October 2012, it appeared that some clinicians would offer
pazopanib in standard practice, as an alternative to sunitinib. Following discussion with the funder and trial oversight groups, it was agreed to include pazopanib, with the type of drug (sunitinib or pazopanib) as a randomisation
stratification factor.
Initially (stages A&B) STAR planned to recruit at least 210 patients from 13 study sites to determine whether recruitment is feasible and the Modified Schedule appears effective. STAR will expand to 38 sites (Stage C), recruiting 1000 patients over 54 months.
Participants are randomised equally at trial entry to receive the Standard Schedule of treatment cycles every 6 weeks until progression OR to have the Modified Schedule with a planned treatment break after 4cycles of treatment. Participants will have clinical assessment 6weekly and CT/MRI scans 12 weekly until evidence of significantly worsening disease whilst receiving treatment.Summary of Results
Treatment breaks in cancer are of significant interest to patients and health professionals.
Renal cell cancer is the most common type of kidney cancer. Sunitinib and pazopanib are both targeted treatments. They were commonly used to treat advanced kidney cancer but often cause side effects, sometime requiring using a reduced dose or even stopping treatment.
The STAR trial was designed to see whether planned treatment breaks made patients with advanced kidney cancer being treated with sunitinib and pazopanib feel better, without substantially affecting how well the treatment worked. After 24 weeks of treatment patients took sunitinib and pazopanib either as they would normally or in the alternative way with planned treatment breaks. Treating patients in this way was continued until drug side effects stopped treatment, patients’ disease worsened whilst taking treatment or the patient died. The trial compared how well the different treatment strategies worked in terms of how long patients lived and their quality of life over that time.
This trial is the largest UK trial in advanced renal cell cancer. Patients took part from 60 UK centres between 2012 and 2017. It was funded by the NIHR HTA Programme and run by the Leeds Clinical Trials Research Unit.
In total 920 patients took part. 461 patients were allocated to continue treatment and 459 were allocated to start at least one treatment break. Treatment breaks lasted on average 87 days. The length of time patients lived in both arms of the trial appeared similar, but this cannot be concluded due to insufficient information. Being allocated to have treatment breaks rather than continuing treatment did not negatively impact a patient’s quality of life. Additionally, allocating patients to have treatment breaks was shown to have significant cost savings compared to just continuing treatment. Importantly planned treatment breaks were shown to be feasible.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
11/NW/0246
Date of REC Opinion
6 Jun 2011
REC opinion
Further Information Favourable Opinion