Bevacizumab With Pelvic Radiotherapy And Primary Chemotherapy in Patients With Poor-Risk Rectal Cancer

Inclusion Criteria

• Patients with histologically or cytologically confirmed diagnosis of locally advanced rectal cancer (LARC) at high risk of recurrence (T4, N+, T3N0 with tumor located in the lower third of the rectum and/or circumferential resection margin (CRM) £5 mm), or LARC with resectable organ metastasis (M1).
• Age 18 years or older
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
• Life expectancy of at least 12 weeks
• Measurable and/or evaluable (resectable organ metastasis)lesions according to RECIST criteria
• Neutrophils > 1500 and Platelets > 100,000 /L
• Total bilirubin 50 mL/min or serum creatinine or = 2+ proteinuria on dipstick urinalysis at baseline, should undergo a 24-hour urine collection and must demonstrate 325 mg/day) or other medications known to predispose to gastrointestinal ulceration.
• Treatment with any investigational drug within 30 days prior to enrolment.
• Patients with known allergy to Chinese hamster ovary cell proteins, or any of the components of the study medications
• Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal and squamous cell carcinoma or cervical cancer in situ
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study.
• Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.