Rectal Cancer And Pre-operative Induction Therapy Followed by Dedicated Operation. The RAPIDO Trial

Prior treatment

• Extensive growth into cranial part of the sacrum (above S3) or the lumbosacral nerve roots indicating that surgery will never be possible even if substantial tumour down-sizing is seen
• Concurrent uncontrolled medical conditions

Other illness

• Presence of metastatic disease or recurrent rectal tumour
• Familial Adenomatosis Polyposis coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohn's disease or active ulcerative Colitis
• Concomitant malignancies, except for adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri. Subjects with prior malignancies must be disease-free for at least 5 years
• Medical or psychiatric conditions that compromise the patient's ability to give informed consent
• Any investigational treatment for rectal cancer within the past month
• Patients with known malabsorption syndromes or a lack of physical integrity of the upper gastrointestinal tract
• Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac dysrhythmia, e.g. atrial fibrillation, even if controlled with medication) or myocardial infarction within the past 12 months
• Patients with symptoms or history of peripheral neuropathy

Other

• Known Dihydro-Pyrimidine Dehydrogenase (DPD) deficiency
• Any contraindications to MRI (e.g. patients with pacemakers)
• Pregnancy or breast feeding

• Primary tumour characteristics:
• Histological proof of newly diagnosed primary adenocarcinoma of the rectum
• Locally advanced tumour fulfilling at least one of the following criteria on pelvic MRI indicating high risk of failing locally and/or systemically (clinical T4a, i.e. overgrowth to an adjacent organ or structure like the prostate, urinary bladder, uterus, sacrum, pelvic floor or side wall (according to tumor node metastasis (TNM-Classification version 5)), clinical T4b, i.e. peritoneal involvement, extramural vascular invasion (EMVI+). N2, i.e. four or more lymph nodes in the mesorectum showing morphological signs on MRI indicating metastatic disease. Positive Mesorectal Fascia (MRF+), i.e. tumor or lymph node \< 1 mm from the mesorectal fascia. Enlarged lateral nodes (LN), \> 1 cm (lat LN+)