Non-Operative Treatment for Rectal Cancer Following Complete Response to Neo-Adjuvant Therapy
- Age > 18 years
- Locally invasive high-risk rectal adenocarcinoma as defined by the presence on MRI of
at least one of the following: i) Tumours within 1mm of mesorectal fascia i.e.
circumferential resection margin threatened or involved ii)T3 tumours at/below
levators iii)Tumours extending ≥5mm into peri-rectal fat iv)T4 tumours (including the
involvement of bladder or vagina if surgical resection is possible with clear
margins) v)Presence of extra-mural venous invasion (primary tumour is therefore at
least T3) vi)T2 N0/1/2 tumours requiring Abdomino-Perineal Excision, within 1mm of
mesorectal fascia i.e. circumferential resection margin threatened or involved
- The absence of malignant pelvic side-wall disease, local recurrence (either after TME
or wide local excision) or metastatic disease
- Completion of pre-operative long-course CRT
- No viable disease seen at MRI performed 4 weeks after long-course CRT, confirmed at 8
- Evidence of partial response of rectal tumour to pre-operative long-course CRT at 4
week MRI which continues to show an incremental response at 8 week MRI.
- Histological diagnosis of adenocarcinoma of rectum.
- WHO performance status 0, 1 or 2.
- No evidence of metastatic disease as determined by CT scan of chest, abdomen, pelvis
or other investigations such as PET scan or biopsy if required.
- Informed written consent
- Age < 18 years.
- Absence of concomitant chemotherapy.
- RT dose below 50Gy.
- Stable disease at 4 week MRI.
- Disease that demonstrates a partial response at 4 week MRI but shows no evidence of
an incremental response at 8 week MRI.
- Pregnancy or breast feeding
- Short course pre-operative radiotherapy
- Previous pelvic radiotherapy
- Medical or psychiatric conditions that compromise the patient's ability to give
- Any contra-indication to MRI scanning, eg Cardiac Pacemaker or Hip prosthesis.
- Any patients within the EXPERT-C trial.
- Tumours which are mucinous (>50% mucin seen on MRI), as these are more likely to be