Conditions: Colorectal Cancer
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 43
Healthy volunteers: no

Brief summary:
This open-label study will assess the efficacy and safety of Avastin (bevacizumab) plus Xeloda (capecitabine) in combination with standard technique radiotherapy of the pelvic region in the neo-adjuvant setting in patients with locally advanced primary rectal cancer. Patients will receive 4 courses of Avastin at a dose of 5 mg/kg intravenously (iv) every 2 weeks and for 38 days Xeloda at dose of 825 mg/kg twice daily orally, plus radiation therapy. After surgery, adjuvant treatment with 5-fluorouracil/leucovorin and, at the discretion of the investigator, with Avastin 5 mg/kg iv every 2 weeks for at least 6 months will be given.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: bevacizumab [Avastin] intervention 2: capecitabine [Xeloda] intervention 3: Radiation therapy intervention 4: Mesorectal excision intervention 5: bevacizumab [Avastin] intervention 6: 5-fluorouracil intervention 7: leucovorin
Intervention descriptions: intervention 1: 5 mg/kg intravenously every 2 weeks, 4 cycles intervention 2: 825 mg/m2 twice daily orally, 38 days intervention 3: Total dose of 45 Gy over 38 days intervention 4: 6-8 weeks after completion of neoadjuvant treatment intervention 5: Post-surgery adjuvant treatment at the discretion of the investigator: 5 mg/kg iv every 2 weeks for at least 6 months intervention 6: Post-surgery adjuvant therapy: bolus of 400mg/m2 iv plus iv infusion of 600 mg/m2 on Days 1 and 2 of each 2-week cycle for 6 months intervention 7: Post-surgery adjuvant treatment: 100 mg/m2 iv on Days 1 and 2 of each 2-week cycle for 6 months

Protocol document: