This protocol addresses patients with rectal cancer clinically staged as T3, N any, with a clear circumferential resection margin (CRM) on MRI — defined as greater than 1 mm from the mesorectal fascia and levator muscles, not invading the intersphincteric plane — or staged as T1–2, N1–2.
Two treatment courses are established for this group: either total neoadjuvant therapy (TNT) followed by transabdominal resection, or a more traditional perioperative approach combining neoadjuvant and adjuvant therapy.
The preceding line consisted of total neoadjuvant therapy (TNT) — chemotherapy with FOLFOX or CAPEOX combined with chemoradiation or short-course RT — or neoadjuvant chemoradiation alone.
Escalation to this protocol is triggered when restaging at 8 weeks after completion of radiotherapy does not demonstrate a complete clinical response — defined as no evidence of residual disease on digital rectal examination, rectal MRI, and direct endoscopic evaluation.
Following formal restaging, management centres on a transabdominal surgical approach in eligible patients. In selected patients who achieve a complete clinical response, a non-operative watch-and-wait strategy may be evaluated at centres with experienced multidisciplinary teams. When surgical resection is not feasible, an alternative systemic approach is employed. The full sequencing and regimen details are in the structured protocol.