A phase II study of oxaliplatin/5-FU/Avastin and concurrent radiation in patients with simultaneous primary and metastatic rectal cancer

Interventions: Single arm study - Integrated preoperative radiotherapy and chemotherapy over 11 weeks.
Treatment: drugs
Oxaliplatin (given intravenously): day 1 of each of weeks 1, 6 and 11 100mg/m2 given; day 1 of each of weeks weeks 3 and 8, 85 mg/m2 given.
Flurouracil: day 1 of each of weeks 1, 6 and 11 400mg/m2 bolus, given intravenously followed on day 1 by continuous infusion 2.4 g/m2, over 46 hours; on days of radiotherapy during both weeks 3-5 and weeks 8-10 - continuous infusion 200mg/m2/day over 96 hours
Leucovorin (given intravenously): day 1 of each of weeks 1, 6 and 11 200mg/m2 given.
Bevacizumab (given intravenously): day 1 of each of weeks 1, 3, 5, 7, 9 and 11 - 5mg/kg
Treatment: Other
Radiation Therapy: in both weeks 3-5 and weeks 8-10 25.2Gy in 14 fractions over 2 weeks and 4 days. A total of 50.4 Gy in 1.8 Gy per fraction is given. The first 45 Gy is given to the pelvic volume and the final 5.4 Gy is given to a boost volume.
Primary outcome(s): Tolerability rate: the percentage of patients who are able to complete the planned treatment program and do not require a treatment break for toxicity.[End of the treatment program (11 weeks)]
Study Design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy