Recent advances in (chemo-)radiation therapy for rectal cancer: a comprehensive review

Radiation Oncology

Table 1 Phase III trials of neoadjuvant concurrent chemoradiation approaches with the addition of oxaliplatin

Trial	Phase	Disease stage	n	Ind. CHT	RT dose⁴	Conc. CHT	Adj. CHT	pCR rate	downstaging	3y-DFS	grade 3+ tox
ARO 2004 [28]	III	T3-4 or N+	1236	None	50.4	5-FU	5-FU	13%	n.r	71%	20%
				None	50.4	5-FU/Ox	5-FU/LV/Ox	17%	n.r	76%	24%
NSABP-R04 [29]¹	III	T3-4 or N1-2	1608	None	50.4–55.8	5-FU or Cap	n.s	18%	n.r	n.r	28%
				None	50.4–55.8	5-FU or Cap+ Ox	n.s	20%	n.r	n.r	41%
ACCORD 12 [30, 35]	III	T3-4 or T2 dist	598	None	45	Cap	n.s	14%	29%⁴	68%	11%
				None	50	Cap/Ox	n.s	19%	39%⁴	73%	25%
STAR-1 [31]	III	T3-4 or N1-2	747	None	50.4	5-FU	5-FU	16%	n.r	n.r	8%
				None	50.4	5-FU/Ox	5-FU	16%	n.r	n.r	24%
PETACC-6 [32]²	III	T3-4 or N+	1094	None	45–50.4	Cap	Cap	11%	44%⁵	74%	15%
				None	45–50.4	Cap/Ox	Cap/Ox	13%	42%⁵	75%	37%
FOWARC [33, 36]³	III	T3-4 or N1-2	330	5-FU/LV	46–50.4	5-FU/LV	5-FU/LV	14%	39%⁶	73%	Tox sig. inc
				mFOLFOX6	46–50.4	mFOLFOX6	mFOLFOX6	28%	60%⁶	77%	With Ox

n: number of patients, RT dose: radiation therapy dose in Gy, conc. CHT: concurrent chemotherapy, ind. CHT: induction chemotherapy (prior to RT), adj. CHT: adjuvant chemotherapy (after surgery), pCR rate: percentage of patients with pathological complete remission, downstaging: percentage of patients with major downstaging defined according to study protocol (only listed if combined T and N downstaging was reported), 3y-DFS: 3 year rate of disease free survival, grade3+ tox: acute toxicity during combined chemoradiation grade 3 or higher (only listed if an overall percentage was reported), dist.: distal, 1: 2 × 2 factorial design after amendment, 2: published as abstract only, 3: three arm design, only arms with radiation therapy reported, 4: defined as DWORAK score 2 and 3, 5: defined as ypT0-2N0, 6: defined as ypstage 0–1, 5-FU: 5-fluorouracil, Ox: Oxaliplatin, Cap: capecitabine, LV: leucovorin, mFOLFOX6: combination regimen of 5-fluorouracil, leucovorin and oxaliplatin, tox sig. inc.: toxicity significantly increased, bold style: indicates significant difference

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