Long-course neoadjuvant chemoradiotherapy with versus without a concomitant boost in locally advanced rectal cancer: a randomized, multicenter, phase II trial (FDRT-002)

Table 2 Acute toxicity according to CTCAE 4.0, on all patients receiving treatment

Adverse Event	Grade 1–2				Grade 3–4				P value*
	Arm A (N = 60)		Arm B (N = 60)		Arm A (N = 60)		Arm B (N = 60)
	No.	%	No.	%	No.	%	No.	%
Diarrhea	21	35.0%	16	26.7%	4	6.7%	6	10.0%	0.721
Nausea	35	58.3%	31	51.7%	2	3.3%	3	5.0%	0.683
Vomiting	5	8.3%	7	11.7%	2	3.3%	2	3.3%	0.608
Anorexia	13	21.7%	18	30.0%	0	0.0%	1	1.7%	0.203
Radiodermatitis	27	45.0%	22	36.7%	8	13.3%	10	16.7%	0.807
Anemia	37	61.7%	34	56.7%	0	0.0%	0	0.0%	0.581
leukopenia	16	26.7%	21	35.0%	2	3.3%	2	3.3%	0.360
Neutropenia	15	25.0%	20	33.3%	2	3.3%	3	5.0%	0.247
Thrombopenia	27	45.0%	25	41.7%	2	3.3%	1	1.7%	0.543
Overall	40	66.7%	43	71.7%	11	18.3%	15	25.0%	0.077

Arm A, 5 weeks of treatment with radiotherapy 50 Gy/25 fractions with concurrent capecitabine 625 mg/m² twice daily 5 days per week and oxaliplatin 50 mg/m² once weekly; Arm B, 5 weeks of treatment with radiotherapy 55 Gy/25 fractions with concurrent capecitabine 625 mg/m² twice daily 5 days per week and oxaliplatin 50 mg/m² once weekly, followed by a cycle of XELOX
Abbreviations: MRF Mesorectal fascia
*All P values are comparison of grade 3 and 4 adverse events between the two arms

ISSN: 1748-717X