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Table 1 Patient inclusion criteria

From: Bevacizumab and Combination Chemotherapy in rectal cancer Until Surgery (BACCHUS): a phase II, multicentre, open-label, randomised study of neoadjuvant chemotherapy alone in patients with high-risk cancer of the rectum

• Histologically confirmed diagnosis of adenocarcinoma of the rectum
• Distal part of the tumour within 4–12 cm of the anal verge
• No unequivocal evidence of established metastatic disease (on chest/abdominal/pelvis CT). Patients with equivocal lesions (as determined at MDT) are eligible
• MRI-evaluated-evaluated locally advanced tumour with the following:
  • T3 tumours extending (≥4 mm), beyond the muscularis propria N0–N2
  • Or tumours (involving or threatening the peritoneal surface) or presence of macroscopic extramural venous invasion (V2 disease)
  • AND for tumours below the peritoneal reflection, the primary tumour or involved lymph node (on MRI) must be >1 mm from the mesorectal fascia
• Measurable disease (using RECIST criteria v1.1)
• WHO performance status 0 – 1
• In the opinion of the investigator:
  ▪ General condition considered suitable for radical pelvic surgery
  ▪ Candidate for systemic therapy with FOLFOX/FOLFOXIRI plus bevacizumab
   ▪ Adequate bone marrow, hepatic and renal function:
   ▪ Haemoglobin ≥80 g/L
  ▪ ANC ≥2 × 109/L
  ▪ Platelet count ≥100 × 109/L
  ▪ ALT or AST ≤1.5 × ULN (upper limit of normal)
  ▪ ALP ≤1.5 × ULN
  ▪ Total bilirubin ≤1.5 × ULN
  ▪ Serum creatinine ≤1.5 × ULN
  ▪ Creatinine clearance ≥50 mL/min using the Cockcroft–Gault formula (see Appendix 4). If the calculated GFR is below <50 ml/min, 51Cr-EDTA or 99mTc-DTPA clearance test must be carried out demonstrating GFR is ≥50 ml/min
• INR ≤ 1.1
• Urine protein ≤1+ with dipstick or urine analysis.
  ▪ For proteinuria >1+ or urine protein/creatinine ratio ≥ 1.0, 24-h urine protein should be obtained and the level must be <2 g for eligibility
• No evidence of established or acute ischaemic heart disease on ECG and normal clinical cardiovascular assessment
• No known significant impairment of intestinal absorption
• At least 18 years of age, but not more than 75 years
• Willing and able to give informed consent, comply with treatment and follow up schedule