An Australian Translational Study to Evaluate the Prognostic Role of Inflammatory Markers in Patients With Metastatic Colorectal Cancer Treated With Bevacizumab (Avastin) [ASCENT]
Inclusion Criteria:
Resected primary tumor patients, and patients with primary tumor in situ:
- Adult patients, >/= 18 years of age
- Previously untreated metastatic colorectal cancer and not a candidate for curative
resection
- WHO performance status of 0-1
- Life expectancy of >/= 3 months
- Eligible for XELOX, mFOLFOX6, FOLFIRI and Avastin treatment in accordance with local
standards of care and pharmaceutical benefits scheme
Additional inclusion criteria for patients with primary tumor in situ:
- Intact primary tumor of the colon or the rectum not requiring surgical intervention
prior to study start
- Minimal or asymptomatic primary tumor
Exclusion Criteria:
Resected primary tumor patients, and patients with primary tumor in situ:
- Previous chemotherapy for metastatic colorectal cancer
- Previous neoadjuvant or adjuvant chemotherapy less than 6 months prior to study start
- Radiotherapy within 28 days prior to enrolment or not recovered from a radiotherapy
- History of non-colorectal cancer (patients are eligible if disease-free for more than
5 years and the risk of recurrence is deemed low)
- Presence of active inflammatory bowel disease
- History of gastrointestinal perforations
- Peritoneal disease
- History of significant bleeding event
- Significant vascular disease
- Peripheral arterial thrombosis or other thrombotic event within 6 months before study
start
Additional exclusion criteria for patients with primary tumor in situ:
- Prior endoscopic management of the current tumor
- Acute diverticulitis
- Presence of intra-abdominal abscess
- Active gastroduodenal ulcer