Table 1.
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.