SHAPERS: Efficacy and safety of short-course radiotherapy (SCRT) versus total neoadjuvant therapy in older patients with locally advanced rectal cancer: a multicentre, open-label, randomised pragmatic clinical trial (KCE-211331)

Summary (Dutch or French)

The management of patients with locally advanced rectal cancer has improved over time, but a substantial proportion of them still succumb to their disease. Therefore, intensive, multimodal, preoperative treatment strategies using radiotherapy and chemotherapy (also known as total neoadjuvant therapy) have increasingly been used in routine clinical practice in order to reduce the risk of cancer recurrence after surgery and improve survival. However, it is debatable whether the survival benefits of using such intensive approaches are large enough to justify the increased risk of treatment-related toxicities and long-term functional sequelae, which can negatively affect quality of life. This concern is especially valid for older patients, who are generally less likely (due to their shorter life expectancy) to benefit from the small incremental survival advantage of total neoadjuvant therapy but more prone than younger patients to suffer toxicities. This clinical trial aims to demonstrate that conventional, less intensive, pre-operative treatment strategies such as radiotherapy alone offer a better trade-off between efficacy and toxicity for locally advanced rectal cancer patients aged ≥70 years, as compared with total neoadjuvant therapy. This study has the potential to establish the optimal care in this setting and to provide physicians and patients with all-round, comprehensive evidence that can be used to inform decision-making, improving overall patient experience during treatment as well as survivorship after treatment.