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. |