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Open Access Study protocol

The 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

Fiona J Collinson1, Walter M Gregory1, Chris McCabe2, Helen Howard1, Catherine Lowe1, DrBarbara Potrata3, Sandy Tubeuf4, Pat Hanlon5, Lucy McParland1, T Wah6, Peter J Selby7, Jenny Hewison8, Julia Brown1 and Janet Brown9*

Author Affiliations

1 Clinical Trials Research Unit, University of Leeds, Leeds, LS2 9JT, UK

2 Academic Unit of Health Economics, Leeds Institute of Health Sciences, Charles Thackrah Building, University of Leeds, 101 Clarendon Road, Leeds, LS2 9LJ, UK

3 Charles Thackrah Building, Leeds Institute of Health Sciences, University of Leeds, Leeds, LS2 9JT, UK

4 Academic Unit of Health Economics, Leeds Institute of Health Sciences, Charles Thackrah Building, University of Leeds, 101 Clarendon Road, Leeds, LS2 9LJ, UK

5 Patient Representative National Cancer Research Institute (NCRI) Renal Cancer Clinical Studies Group, Leeds, UK

6 Department of Radiology St James’s University Hospital, Leeds, LS9 7TF, UK

7 Cancer Research Building, St James’s University Hospital, Leeds, LS9 7TF, UK

8 Charles Thackrah Building, Leeds Institute of Health Sciences, University of Leeds, Leeds, LS2 9TF, UK

9 Cancer Research UK Experimental Centres at Leeds and Sheffield, Leeds, LS2 9TF, UK

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BMC Cancer 2012, 12:598  doi:10.1186/1471-2407-12-598

Published: 14 December 2012

Abstract

Background

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.

Methods/Design

The STAR trial is an NIHR HTA-funded UK pragmatic randomised phase II/III clinical trial in the first-line treatment of advanced RCC. Participants will be randomised (1:1) to either a sunitinib CCS or a DFIS. The overall aim of the trial is to determine whether a DFIS is non-inferior, in terms of 2-year overall survival (OS) and quality adjusted life years (QALY) (averaged over treatment and follow up), compared to a CCS. The QALY primary endpoint was selected to assess whether any detriment in terms of OS could be balanced with improvements in quality of life (QoL). This is a complex trial with a number of design challenges, and to address these issues a feasibility stage is incorporated into the trial design. Predetermined recruitment (stage A) and efficacy (stage B) intermediary endpoints must be met to allow continuation to the overall phase III trial (stage C). An integral qualitative patient preference and understanding study will occur alongside the feasibility stage to investigate patients’ feelings regarding participation or non-participation in the trial.

Discussion

The optimal duration of continuing sunitinib in advanced RCC is unknown. Novel targeted therapies do not always have the same constraints to treatment duration as standard chemotherapeutic agents and currently there are no randomised data comparing different treatment durations. Incorporating planned treatment breaks has the potential to improve QoL and cost effectiveness, hopefully without significant detriment on OS, as has been demonstrated in other cancer types with other treatments.

Trial Registration

Controlled-trials.com ISRCTN 06473203

Keywords:
Renal cancer; Sunitinib; Intermittent treatment; Quality of life; Quality adjusted life years; Health economics