Bevacizumab in the pre-operative treatment of locally advanced rectal cancer: A systematic review

Table 5 Main ongoing trials with bevacizumab in locally-advanced rectal cancer

Study	Design	n	Pre-operative treatment	RT	Primary endpoint	Status	Comments
AXE BEAM trial (NCT00828672)	Randomized	80	Concomitant XELOX +/- BV + RT	CT-RT	pCR	Recruiting
	Phase II			45 Gy
New Beat trial (NCT01554059)	Phase II	28	Concomitant FOLFOX + BV + RT	CT-RT	pCR	Recruiting
				40 Gy/20 fractions
NCT01818973	Phase II	45	XELOX + BV for 1 cycle followed by concomitant CT-RT with XELOX + BV for 2 cycles and RT	CT-RT	Tumor regression grade	Recruiting	Adjuvant CT with XELOX for 3 cycles followed by capecitabine for 2 cycles
				50 Gy/25 fractions
BACCHUS trial (NCT01650428)	RandomizedPhase II	60	FOLFOX + BV for 5 cycles followed by FOLFOX for 1 cycle vs FOLFOXIRI + BV for 5 cycles followed by FOLFOXIRI for 1 cycle	No	pCR	Recruiting	Magnetic resonance imaging-defined poor risk criteria
NCT01871571	Phase II	43	mFOLFOX7 + BV for 6 cycles	No	pCR	Recruiting
NCT00865189	Randomized Phase II	91	FOLFOX + BV for 6 cycles followed by CT-RT with BV and 5-FU vs CT-RT alone	CT-RT	pCR	Ongoing, not recruiting	Not specified RT dose and fractioning
NCT00462501	Phase II	36	FOLFOX + BV for 4 cycles followed by FOLFOX for 2 cycles with selective use of CT-RT with 5-FU in patients not candidate for R0 resection	CT-RT	R0 resection rate	Ongoing, not recruiting	Not specified RT dose and fractioning
TRUST trial (EUDRACT 2011-003340-45)	Phase II	43	FOLFOXIRI + BV for 6 cycles followed by CTRT with BV and capecitabine or 5-FU	CT-RT 50.4 Gy/28 fractions	DFS rate at 2 yr	Recruiting

LARC: Locally-advanced rectal cancer; BV: Bevacizumab; RT: Radiotherapy; CT: Chemotherapy; CT-RT: Chemo-radiotherapy; pCR: Pathological complete response; DFS: Disease-free survival; 5-FU: Fluorouracil; XELOX: Capecitabine and oxaliplatin; FOLFOX: 5-FU and oxaliplatin; FOLFOXIRI: 5-FU, oxaliplatin and irinotecan.