Locally advanced colon and rectal cancer

1. Cohort A and B: T1-3, N1/N1c
2. Pathologic stages II or IIIC w/commercially obtained Signatera ctDNA+ve assay are eligible for enrollment and inclusion in Cohort B
3. Ro resection
4. Consented and randomized < 60 days from surgical resection

T1-2N0 and must be able to a TEMS candidate with surgery

- Histologically confirmed invasive, well-moderately differentiated rectal adenocarcinoma,
mismatch repair proficient.

- MRI stage:
a) cT1 not eligible for transanal surgery alone as per NCCN guidelines, (including but not limited
to T1 tumours >2 cm in size, positive margin, tumour depth SM3 invasion to the lower third of the
submucosal level).
or
b) cT2


- cN0 stage based on pelvic MRI – including absence of radiographic evidence of mesorectal nodal
metastasis, tumour deposits or extramural venous invasion (EMVI).

- M0 stage based on no evidence of metastatic disease by CT imaging of chest, abdomen and pelvis.

- Mid to low-lying tumour eligible for transanal excision in the opinion of the treating surgeon.

- Medically fit to undergo radical TME surgery as per treating surgeon’s decision