SORT: Surgery Or RadioTherapy for early-stage cancer

Research questions For patients with early-stage non-small cell lung cancer (NSCLC), oesophageal squamous cell carcinoma (OSCC), and muscle-invasive bladder cancer (MIBC), we will ask: a) what impact did the COVID-19 period have on sociodemographic inequalities in receipt of curative versus non-curative interventions? b) what is the relative effectiveness and cost-effectiveness of curative radiotherapy (RT) versus surgery? Background For people with early stage NSCLC, OSCC, or MIBC prognosis is poor. Surgical resection is the mainstay curative treatment for these early stage tumours. Radical RT is a recommended alternative, but there is limited RCT evidence comparing curative RT with surgery. To improve outcomes for these three early-stage cancers it is essential to know which of these curative interventions is more effective and cost-effective. The objectives are: 1. To describe the influence of patient and organisational factors on the use of curative RT, curative surgery or non-curative strategies 2. To assess inequalities in the receipt of curative versus non-curative interventions 3. To assess the effectiveness of curative RT versus curative surgical strategies 4. To assess the cost-effectiveness of curative RT versus curative surgical strategies For each cancer, we will synthesise the findings to report: the curative intervention that is more effective and more cost-effective, inequalities in receipt of curative interventions, and the local organisational and patient factors, that may influence treatment choice. We will report results for time periods before and during the COVID-19 pandemic. Methods The overall design combines linked routine cancer data with insights from clinical panels, and interviews with people with each cancer. We will describe the influence of organisational and patient-level factors on use of curative RT or surgical strategies for each early stage tumour. We will assess inequalities according to sociodemographic characteristics (e.g. deprivation, ethnicity) in receipt of curative versus non-curative interventions for each cancer. We will conduct target trials, that apply the principles of an RCT design to observational data, to assess the relative effectiveness of curative RT versus surgery for each cancer. This will involve drawing on clinical panels to help define the eligibility criteria, and treatment strategy protocols, from the cancer registry data. The main outcome will be two-year mortality from the date of diagnosis. We will assess the comparative effectiveness of curative RT versus surgery adjusting for measured patient and organisational factors between the groups. We will use the patient'Äôs travel time to the nearest RT centre, as an instrumental variable to minimise residual confounding. We will assess the relative cost-effectiveness of curative RT versus surgical strategies for each early-stage cancer. Timelines for delivery: Clinical panels, patient interviews, study protocols (months 0-18); inequalities analysis (months 6-18), target trials (18 to 33), CEA (21 to 33), translation workshop and final project report (33-36). Anticipated impact and dissemination: We will convene a translation workshop with all stakeholders including professional surgical and oncological groups, Public and Patient representatives and policymakers from NHS England and NICE. We will discuss how the overall findings can help improve service provision, patient choice and outcomes for these three major cancers.