Recommendations for Randomised Trials in Surgical Oncology

Abstract

Trials of surgical procedures in the treatment of malignant disease face a unique set of challenges. This review aimed to describe recommendations for the design, delivery and reporting of randomised trials in surgical oncology. A literature search was carried out without date limits to identify articles related to trial methodology research in surgery and surgical oncology. A narrative review was framed around two open National Institute of Health Research portfolio trials in colon and rectal cancer: the STAR-TREC trial (ISRCTN14240288) and the ROCCS trial (ISRCTN46330337). Twelve specific challenges were highlighted: standardisation of technique; pilot and feasibility studies; balancing treatments; the recruitment pathway; outcome measures; patient and public representation; trainee-led networks; randomisation; novel techniques and training; learning curves; blinding; follow-up. Evidence-based recommendations were made for the future design and conduct of surgical oncology trials. Better understanding of the challenges facing trials in the surgical treatment of cancer will accelerate high-quality evaluation and rapid adoption of innovation for the benefit of patient care.

Modern Challenges of Cancer Clinical Trials

“…Although the process of evaluating drug treatments has evolved over decades, approaches to assess novel surgical and radiotherapy techniques are less well developed. In their article, Glasbey et al [12] highlight 12 unique challenges of and recommendations for survival oncology trials based on two open trials in colon and rectal cancer, namely the STAR-TREC and ROCCS trials. With respect to radiotherapy studies, Faivre-Finn et al [13] share their experience with CONVERT, a landmark trial in limited-stage small cell lung cancer in the modern era of positron emission tomography/computed tomography staging and advanced radiotherapy techniques that took 15 years from conception to completion.…”

Challenging traditional research: A synopsis of the National Research Collaborative Meeting (NRCM) in 2017

“…Within national and international settings, surgical trainees have been empowered to and increasingly involved in multi-centre, prospective cohort studies [5], [6], [7]. The traditional challenges of clinical trials such as recruitment and describing uncertainty, standardisation and training of novel surgical interventions, and learning curve effects provides an extra layer of complexity to trainees wished to be involved in research [8], [9]. However, trainees can be supported in developing and leading clinical trials with access to senior trialists and the infrastructure from established clinical trials units (CTUs) through the research collaboratives [3].…”