Deferral of surgery study

Timing and Deferral of Rectal Surgery Following a Continued  Response to Pre-operative Chemoradiotherapy

The standard treatment for locally advanced rectal cancer or low rectal cancer is neoadjuvant chemoradiotherapy (CRT) followed by surgery, either anterior resection or abdominal peritoneal resection respectively. The latter means that patients undergoing this procedure will require a life long stoma.

10-25% of patients would develop complete pathological response (pCR) after CRT for rectal cancer. Surgery presently remains standard of care for these patients, but there is significant morbidity and mortality associated with rectal surgery in elderly patients and those with significant co-morbidities. Results from the United Kingdom National Bowel Cancer project shows that the 30-day mortality rate after rectal surgery is significantly higher for patients over the age of 75 years compared with younger patients.

Traditionally, rectal surgery takes place 6 weeks after CRT, but maximal tumour down-staging may require a longer period of time depending on individual tumour response. Some patients with a good continuing partial response at the end of CRT may have better surgical outcomes if they defer surgery until the time of maximal tumour response. The optimal time to maximal response is currently unknown, so the optimal imaging timetable for such patients at present is unclear.

This study is designed to establish the time to maximum tumour response following CRT, and to investigate whether surgery can be safely avoided within the tight framework of the trial follow-up schedule in a small group of patients where the cancer becomes undetectable by imaging modalities.

The study uses MRI in combination with FDG-PET CT and clinical examination (tri-modality assessment) to assess for a continued incremental response to CRT. Surgery is NOT withheld from patients entering this study. Indeed, surgery is an option at each stage of patient follow-up based on:

• There being no further incremental imaging response and complete response not achieved
• Evidence of tumour regrowth (clinical imaging, endoscopy or tumour marker)
• Patient Choice
• If a status of `no detectable disease` by serial MRI, CT-PET and clinical assessment is achieved and the patient wishes not to have surgery, they will continue to be carefully monitored within the framework of the trial follow-up protocol.

If you are a centre interested in participating or requiring further information in the Timing and Deferral of Rectal Surgery Following a Continued Response to Pre-operative Chemoradiotherapy study, please contact Primary Investigator, Dr Diana Tait at This e-mail address is being protected from spambots. You need JavaScript enabled to view it or Clinical Research Fellow, Dr Stanley Yu at This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

Datasheets:

• Protocol
• Protocol Appendix
• Watch and Wait Feasibility Checklist
• Visio-deferral of Surgery CRF
• GP Letter
• Patient Information Sheet