Conditions: Locally Advanced Rectal Cancer
Keywords: bevacizumab capecitabine radiation therapy oxaliplatin multimodality treatments TME (total mesorectal excision) Axe Beam rectal cancer neoadjuvant pathological complete response postoperative complications
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 84
Healthy volunteers: no

Brief summary:
Phase II clinical trial, open-label, randomized, two arms, multicentre (possibly multinational). Academic, investigator initiated.

To assess the activity of bevacizumab (AvastinTM) in combination with capecitabine (XelodaTM) and radiation therapy with or without oxaliplatin (EloxatinTM) in the pre-operative treatment of locally advanced rectal cancer, followed by TME (total mesorectal excision).

Detailed description:
See Synopsis

Arms:
arm 1: Oxaliplatin, Bevacizumab and Capecitabine concurrently with radiotherapy. arm 2: Bevacizumab and Capecitabine concurrently with radiotherapy

Interventions: intervention 1: Oxaliplatin intervention 2: Bevacizumab intervention 3: Capecitabine intervention 4: radiotherapy
Intervention descriptions: intervention 1: Administered on days 15,22,29,36 en 43; 50 mg/m2 intervention 2: Administered on days 1,15,29 and 43 ; 5mg/kg intervention 3: 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy intervention 4: Total dose 45Gy

Protocol document: