Title: Willingness of clinicians and patients to randomise into a study comparing radio frequency ablation (RFA) with active surveillance in the management of incidentally diagnosed small renal tumours: a feasibility study
Funder: Department of Health (England)

Abstract: Design: A mixed methods study incorporating an exploratory pre-pilot phase and a pragmatic multicentre randomised feasibility trial with parallel qualitative process evaluation.Setting: Pre-pilot work with patients will be conducted in the North East. The pilot feasibility trial will be carried out in 6 centres in the UK currently offering either cryotherapy or radiofrequency ablation for small renal cancers. Target population: People with small renal cancer (<4cm). Patients incidentally found to have an exophytic solid renal mass <4 cm on routine ultrasound or CT scan of the abdomen. The patients would undergo contrast enhanced CT scan. Enhancement of >20 Hounsfield unit of the renal mass would be accepted as a sign of malignancy. The patients would undergo biopsy to give histological confirmation of renal cell carcinoma RCC.Exclusion Criteria: Patients in whom the clinician does not feel would be suitable; Fuhrman grade 3/4; ASA grade 3/4 with significant medical co-morbidities; Multiple small renal cancers; Uncorrectable Coagulopathy.Health technologies being assessed: Active surveillance and ablative treatment (radio frequency ablation and cryotherapy). Currently centres have tended to develop expertise in either cryotherapy or radiofrequency ablation (RFA). Where as RFA is only offered percutaneously cryotherapy is offered both percutaneously and laparoscopically. We have recruited three centres providing radio frequency ablation and three centres providing cryotherapy (percutaneously /laparoscopically) so that overall the ratio of treatments within the feasibility trial will be 2:1:1. In keeping with current practice initial surgical/ablative treatment will be carried out within four weeks of randomisation. Close clinical follow up will be a feature of both interventions with CT scans three and six and months Measurement of costs and outcomes: The aim of this study is to establish whether a future definitive trial comparing active surveillance with ablative treatment for small kidney cancer is feasible. This will be assessed quantitatively in terms of recruitment and retention rates and qualitatively in terms of the patients’ experiences and understanding of the randomisation process and treatment options. Reasons for loss to follow up together with clinical data will allow us to project likely retention at 5 years. The primary outcome of the definitive trial would be recurrence of cancer at 5 years post randomisation assessed via CT scan. CT scans are also carried out routinely in this group up to 5 year post treatment; in the feasibility study we will rehearse the procedures for assessment of recurrence at six month.All secondary outcomes will be rehearsed during the feasibility study with a view to refining the choice of outcomes for the main trial based on data yield and quality. These include: persistence of cancer at six months post treatment assessed via CT scan+ a biopsy (performed under local anaesthetic) complications of treatment in the ablative group; a general health questionnaire (SF-36); cancer specific health status and quality of life (FACT-G); anxiety (STAI). We will also pilot the collection of cost data and seek to identify the key cost drivers that may lead to significant cost differences in a full trial. The economic aspect will assess the mechanism of data collection and ease of access to information on resource use of the interventions and pilot the use of data collection instruments for both health outcomes and costs. Cost-effectiveness and cost-utility analyses will be rehearsed to inform the study hypothesis and the analysis plan for the definitive trial.


Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING;6.5 RADIOTHERAPY AND OTHER NON-INVASIVE THERAPIES
Health categories: CANCER AND NEOPLASMS