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.

Nilsson et al.

Nilsson et al. BMC Cancer 2013 13:279   doi:10.1186/1471-2407-13-279

Open Data