Inclusion criteria, exclusion criteria and study summary
There are approximately 16,000 new cases of rectal cancer in the UK per year. Surgery is the mainstay of treatment which is associated with peri-operative mortality and long-term morbidity. Locally advanced disease is treated initially with preoperative radiotherapy, in the main using long-course chemo-radiotherapy (LCCRT) at 45 to 50 Gy, followed by major surgery 8 to 15 weeks later (referred to in this protocol as standard surgical pathway) or selectively by short-course radiotherapy (SCRT) at 25 Gy, traditionally followed by major surgery within 10 days, but based on modern trial results, increasingly major surgery is being delayed for 6 to 8 weeks. In 10% to 20% of cases, chemo-radiotherapy (CRT) may result in a complete disappearance of the rectal tumour. In patients without residual tumour on imaging and endoscopy (clinical complete response [cCR]), a watch-and-wait (W&W) policy (omission of surgery with follow-up) might be considered as an alternate to major resection. This represents a new paradigm for treating rectal cancer. But there are concerns that this approach is oncologically unsafe outside published series from selected specialised centres. While randomised trials would represent the ideal way to evaluate the natural history and efficiency of W&W in patients with cCR, there is a general international option that such trials are “unlikely” and that investigators have observed that “many patients ….. express a strong preference not to undergo major surgery”. Thus, there is a continuing need to prospectively collect clinical data in a standardised manner to monitor the natural history of patients with CCR managed by W&W.
