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Table 2 Patient exclusion 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

The following are exclusion criteria
1. Primary tumour or lymph node on MRI
  • Extending <1mm from, or breaching the mesorectal fascia and therefore the circumferential resection margin,
  • Disease outside of the mesorectal envelope (internal iliac/lateral pelvic lymph node),
2. Clinically significant cardiovascular or coronary disease ≤2 years before randomisation,
3. History of interstitial lung disease or evidence of interstitial lung disease on baseline chest CT scan
4. History of an arterial thromboembolic event during the previous 2 years
5. Evidence of bleeding problems or coagulopathy (Patients receiving warfarin/coumarin derived anticoagulants at full therapeutic doses are excluded, but prophylactic doses of 1 mg to prevent Hickman line clotting are eligible).
6. Significant and continuing rectal bleeding leading to a haemoglobin <80 g/L
7. Chronic use of aspirin (>325 mg/day) or clopidrogel (>75 mg/day) within 10 days of first planned study treatment;
8. Taking phenytoin or sorivudine or its chemically related analogues, such as brivudine
8. Patients requiring regular use of anti-diarrhoeal medication; (NB Patients with ileostomy will not be able to participate if they require regular use of anti-diarrhoeal agents)
9. Serious uncontrolled intercurrent illness including poorly controlled diabetes mellitus;
10. Metallic colonic or rectal stent in situ
11. Previous pelvic radiotherapy;
12. Previous treatment with another investigational agent within 30 days prior to randomisation;
13. Patients with a history of previous malignancy in the past 5 years, excepting basocellular or squamous cell skin cancer, or properly treated cervicouterine cancer in situ;
14. Known HIV, HBV or HCV infection;
15. Pregnant or lactating women or pre-menopausal women not using adequate contraception;
16. Current smoker, or clinically relevant history of drug or alcohol abuse;
17. Patients with any other condition or concurrent medical or psychiatric disease who, in the opinion of the investigator, are not eligible to enter the study.