Biocurcumin as Radiosensitiser for Cervical Cancer Study (BRACES): A Double-Blind Randomised Placebo-Controlled Trial

Table 4

Clinical response based on RECIST.

Variable	Number of patients power = 40.8%	BCM-95 (n = 28)	Placebo (n = 22)	value for protocol	value for ITT
Therapy response (RECIST)				0.61	0.90
Complete	23 (46%)	12 (42.8%)	11 (50%)
Non-complete	27 (54%)	16 (57.2%)	11 (50%)
Post-radiation tumor mass (mm)				0.18	0.86
Min–max	0–79	0–79	0–38
Median (variance)	0 (358.2)	72 (483.5)	70 (154.6)
Mean^+ (SD)	1.5 (1.6)	1.7 (1.7)	1.1 (1.5)	0.41	0.91
Delta of tumor mmass (%)				0.39	0.95
Min–max	100–12	100–12	100–20
Median (variance)	71 (514.4)	89.4 (29.03)	100 (27.1)
Mean^+ (SD)	−63.2 (40.1)	−59.2 (41.1)	−69.1 (39.0)	0.43	0.91

⁺Mean value was transformed to log-mean for statistical analysis. Delta is postradiation result − preradiation result.