Table 2

Eligibility criteria
Inclusion criteria
   Resected primary tumour population
   1.  Signed informed consent obtained prior to any  study specific procedures and willingness to comply  with study requirements (including biomarker  sampling and tumour sampling for biomarkers).
   2.  Patients must be ≥ 18 years old.
   3.  Histologically confirmed, previously untreated mCRC  and not a candidate for curative resection.
   4.  WHO performance status of 0–1.
   5.  Life expectancy of ≥ 3 months.
   6.  Eligible for XELOX, mFOLFOX6, FOLFIRI and  bevacizumab treatment in accordance with local  standards of care and guidelines.
   Patients with primary tumour in situ
     Resected primary tumour population inclusion criteria apply to the following criteria:
   1.  Intact primary tumour of the colon or rectum not  requiring surgical intervention prior to  commencing chemotherapy.
   2.  Minimally or asymptomatic primary tumour  (without obstruction, perforation or active  bleeding requiring transfusion).
Exclusion criteria
   Resected primary tumour population
   1.  Previous chemotherapy for mCRC.
   2.  Previous neoadjuvant or adjuvant chemotherapy  completed within 6 months prior to commencement  of study treatment.
   3.  Radiotherapy within 28 days prior to enrolment or  from which patients have not yet recovered.
   4.  History of non-colorectal cancer (patients are eligible if  they have been disease-free for ≥ 5 years and the risk  for recurrence is deemed low).
   5.  Presence of active inflammatory bowel disease.
   6.  History of gastrointestinal perforation.
   7.  Symptomatic or bulky peritoneal disease.
   8.  History of significant bleeding event(s).
   9.  Significant vascular disease.
   10.  Peripheral arterial thrombosis or other thrombotic  event within 6 months prior to commencement of  study treatment.
   Patients with primary tumour in situ
     Resected primary tumour population exclusion criteria apply in addition to the following criteria:
   1.  Prior endoscopic management of the  current malignancy.
   2.  Acute diverticulitis.
   3.  Presence of intra-abdominal abscess.
   4.  Active gastroduodenal ulcer(s).

Clarke et al.

Clarke et al. BMC Cancer 2013 13:120   doi:10.1186/1471-2407-13-120

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