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). |