A Study of Bevacizumab (Avastin) in Participants With Newly Diagnosed Locally Advanced Rectal Cancer

Efficacy and Safety of Two Neoadjuvant Strategies With Bevacizumab in Locally Advanced Resectable Rectal Cancer: A Randomized, Non-Comparative Phase II Study

This study will assess the efficacy and safety of two different neoadjuvant treatment approaches including bevacizumab in newly diagnosed participants with high risk locally advanced rectal cancer. Participants will be randomized into one of two treatment arms (Arm A or Arm B).

Inclusion Criteria:

• histologically confirmed locally advanced rectal cancer;
• measurable disease;
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

Exclusion Criteria:

• prior treatment with bevacizumab;
• prior radiotherapy to pelvic region, or previous cytotoxic chemotherapy;
• previous history of malignancy (other than basal and squamous cell cancer of the skin, or in situ cancer of the cervix);
• history or evidence of central nervous system (CNS) disease;
• clinically significant cardiovascular disease;
• chronic treatment with high dose aspirin (more than [>] 325 milligrams per day [mg/day]) or non-steroidal anti-inflammatory drugs.