ANGIOPREDICT. ICORG 12-16, V3

Study Design:

Type of Study: Exploratory, translational, multicenter and multinational Phase II study.

Patient Population:All patients from the intent-to-treat population with aCRC or mCRC, (incurable with any conventional multimodality approach) and who fulfil all inclusion and exclusion criteria.

Number of Patients: 224

Sample Type:

Serial tissue and blood samples will be collected before (week 0), during (week 6, month 3 and 6) and at the end of treatment (month 12).

Inclusion criteria

• Patients ≥ 18 years of age.
• Patients diagnosed with recurrent or de novo, locally advanced (unresectable) or metastatic adenocarcinoma of the colon or rectum.
• Planned combination bevacizumab (bvz) treatment with either:

• leucovorin, fluorouracil and oxaliplatin (FOLFOX)
• capecitabine and oxaliplatin (XELOX)
• leucovorin, fluorouracil and irinotecan (FOLFIRI)
• capecitabine and irinotecan (XELIRI)
• Naive for bvz
• An evaluable site of disease
• ECOG Performance status 0, 1, or 2
• Adequate renal function as shown by serum creatinine ≤ 1.5 x ULN or GFR ≥ 50ml/min
• Adequate hematopoietic function [white blood cell (WBC) count ≥ 3000/μl, absolute neutrophil count (ANC) ≥1500/μl, platelets ≥100 000/μl, haemoglobin level ≥ 9.0 g/dl]
• Adequate end organ function, defined as the following: total bilirubin < 1.5 x ULN, SGOT and SGPT < 3.0 x ULN (in case of liver metastases SGOT and SGPT < 5.0 x ULN)
• Ability to give signed informed consent prior to any screening procedures
• FFPE Tissue is available

Exclusion criteria

• Patient has received any other investigational product within 28 days of first day of study drug dosing
• Patients having familial and/or hereditary CRC
• CRC associated with ulcerative colitis
• Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.