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Population: Patients with biopsy proven adenocarcinoma of the rectum, staged as TX/T1/T2/T3, NX/N0, MX/M0 via MRI or ERUS, ECOG PS 0-1, choosing an organ preserving treatment and randomised to receive either long-course chemoradiotherapy (Radiotherapy 25x2Gy plus concurrent capecitabine 825 mg/m2 bd on radiotherapy days over 5 weeks) or short-course radiotherapy (5x5Gy over 5 days). Patients showing tumour progression, poor or no response to (chemo) radiation at 11-13 weeks will undergo Total Mesorectal Excision (TME) surgery. Patients showing incomplete response at 16-20 weeks will undergo Transanal Endoscopic Microsurgery (TEM). Identification of high-risk histopathological features in TEM specimens will prompt conversion to TME. Samples taken: A) Blood derived ctDNA obtained at randomisation, week 16-20 and 6, 12, 18 and 24 months from the start of (chemo)radiotherapy. B) Formalin-fixed paraffin embedded tissue blocks obtained from the biopsy specimen taken to confirm presence of rectal adenocarcinoma and from any subsequent surgical procedure (TEM and/or TME) required to excise the tumour.

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Last Updated: 10/13/2020

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