Trial Information
Status:
Open
Specialty:
Colorectal
Date Opened:
19/01/2022
Planned Close date:
30/11/2022
Sponsors:
The Christie NHS Foundation Trust
Site Recruitment:
15 /
3
Principal Investigator:
Dr Deborah Williamson
Study Title:
OnCoRe
Contacts
Research Nurse / Study Coordinator:
Zainab Chauhan
Administrator:
-
Oncological Outcomes after Clinical Complete Response in Patients with Rectal Cancer
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.
Inclusion criteria for this protocol
The intended core future prospective data will be those required to meet the primary aim – namely, routinely collected clinical data:
i) In patients with rectal cancer following clinical complete response to chemoradiotherapy or radiotherapy and managed by watch-and-wait used internationally recognised criteria defined by Habr-Gama and colleagues (8). These criteria are a
set of clinical, endoluminal, and radiological (typically with magnetic resonance imaging, MRI). The core future data include follow-up within the dates set under the heading ‘Follow-up’.
ii) In patients rectal cancer who on histological examination after surgical resection are deemed to have a pathological complete response following chemo-radiotherapy or radiotherapy i.e. ypT0.
iii) In addition, we seek to include prospectively routinely collected clinical data in patients with rectal cancer and determined through MDT to have: a clinical near complete response following chemo-radiotherapy or radiotherapy – and treated either
by W&W; transanal endoscopic micro-dissection (TEM); or contact radiotherapy or brachytherapy; or major resection. Again, these prospective data include follow-up within the datesets under the heading ‘Follow-up’
The intended core future prospective data will be those required to meet the primary aim – namely, routinely collected clinical data:
i) In patients with rectal cancer following clinical complete response to chemoradiotherapy or radiotherapy and managed by watch-and-wait used internationally recognised criteria defined by Habr-Gama and colleagues (8). These criteria are a
set of clinical, endoluminal, and radiological (typically with magnetic resonance imaging, MRI). The core future data include follow-up within the dates set under the heading ‘Follow-up’.
ii) In patients rectal cancer who on histological examination after surgical resection are deemed to have a pathological complete response following chemo-radiotherapy or radiotherapy i.e. ypT0.
iii) In addition, we seek to include prospectively routinely collected clinical data in patients with rectal cancer and determined through MDT to have: a clinical near complete response following chemo-radiotherapy or radiotherapy – and treated either
by W&W; transanal endoscopic micro-dissection (TEM); or contact radiotherapy or brachytherapy; or major resection. Again, these prospective data include follow-up within the datesets under the heading ‘Follow-up’
not stated.