Table 1.

Inclusion and exclusion criteria

Inclusion criteria
General	Age ≥ 18 years
	ECOG performance score ≤ 1
	Written informed consent
	Staging done within 5 weeks prior to randomization
	Adequate potential for follow-up
	Mentally and physically fit for chemotherapy
	Adequate blood counts:
	White blood cell count ≥4.0 x 109/L
	Platelet count ≥100 x 109/L
	Clinically acceptable haemoglobin levels
	Creatinine levels indicating renal clearance ≥ 50 ml/min
	Bilirubin < 35 μmol/L
Primary tumour characteristics	Biopsy proven rectal adenocarcinoma*
	Locally advanced tumour fulfilling at least one of the following criteria on pelvic MRI:
	cT4a
	cT4b
	cN2
	Extramural vascular invasion (EMVI+)
	Involved mesorectal fascia (MRF+)
	Metastatic lateral lymphnodes (LN+)
Exclusion criteria	Extensive tumour growth into sacrum above S3
	Tumour involving lumbosacral nerve roots
	Distant metastasis (M1)
	Recurrent rectal cancer
	FAP or HNPCC
	Active Crohn’s disease or ulcerative colitis
	Concomitant malignancies (except basocellular carcinoma or in-situ cervical carcinoma)
	Known DPD deficiency
	Contraindications to MRI (e.g. pacemaker)
	Inability to give informed consent
	Concurrent uncontrolled medical condition
	Any investigational treatment for rectal cancer within past month
	Pregnancy or breast feeding
	Known malabsorption syndromes or lack of physical integrity of upper gastrointestinal tract
	Myocardial infarction within past 12 months or clinically significant cardiac disease
	Symptoms or history of peripheral neuropathy

ECOG Eastern Cooperative Oncology Group, * lower border of tumour < 16 cm with a rigid rectoscope, MRI Magnetic resonance imaging, cT4a, cT4b and cN2: Clinical stage according to TNM version 5, S3: sacral vertebra 3, FAP Familial adenomatous polyposis, HNPCC Hereditary non-polyposis colorectal cancer, DPD Dihydropyrimidine dehydrogenase.