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

Table 1 Baseline characteristics of patients (N = 120)

	Arm A		Arm B		Total		P value
	No.	%	No.	%	No.	%	P value
Gender
Male	42	70.00%	42	70.00%	84	70.00%
Female	18	30.00%	18	30.00%	36	30.00%	1.000
Age, years
< =55	27	45.00%	27	45.00%	54	45.00%
> 55	33	55.00%	33	55.00%	66	55.00%	1.000
Clinical T stage
T3	40	66.70%	45	75.00%	85	70.80%
T4	20	33.30%	15	25.00%	35	29.20%	0.315
Clinical N stage
N0	14	23.30%	14	23.30%	28	23.30%
N+	46	76.70%	46	76.70%	92	76.70%	1.000
MRF
-	36	60.00%	38	63.30%	74	61.70%
+	24	40.00%	22	36.70%	46	38.30%	0.707
Location from anal verge, cm
< =5 cm	40	66.70%	40	66.70%	80	66.70%
> 5 cm	20	33.30%	20	33.30%	40	33.30%	1.000
Length of the tumor
< =5 cm	31	51.70%	22	36.70%	53	44.20%
> 5 cm	29	48.30%	38	63.30%	67	55.80%	0.098
Total	60	50%	60	50%	120	100%

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

ISSN: 1748-717X