High-dose radiotherapy (60 Gy) with oral UFT/folinic acid and escalating doses of oxaliplatin in patients with non-resectable locally advanced rectal cancer (LARC): A phase I trial

Figures & data

Table I. Oxaliplatin dose escalation levels and number of patients.

		Planned oxaliplatin dose mg/m^2			Given oxaliplatin dose mg/m^2
	No	Tegafox 1	RCT	Tegafox 2	Tegafox 1	RCT	Tegafox 2
Level 0	6	130	30 × 6	130	130	30 × 6	130
Level 1	6	130	40 × 6	130	130	40 × 6	130
Level 2	3	130	50 × 6	130	130	50 × 6	130
Level 3	3	130	60 × 6	130	130	60 × 5*	130**

*All pts missed ox during one week of RT.

**Two patients did not receive 2. TEGAFOX.

Table II. Worst toxicity according to CTC version 2.0 at each dose level. Number of patients experiencing grade 1–2 and 3 toxicity, respectively.

	Level 0	Level 1	Level 2	Level 3
	Grade 1–2 / 3	Grade 1–2 / 3	Grade 1–2 / 3	Grade 1–2 / 3
No. of patients	6	6	3	3
Nausea/vomiting	5 / 0	4 / 0	3 / 0	1 / 2
Diarrhea	4 / 0	3 / 1	3 / 0	2 / 1
Skin	2 / 0	0 / 1	1 / 0	0 / 0
Fatigue	3 / 1	5 / 1	3 / 0	2 / 1
Pain	4 / 0	2 / 1	3 / 0	0 / 2

Figure 1. Kaplan-Meier curve of recurrence-free survival for 18 patients with non-resectable LARC. Patients received one course of Tegafox before and after CRT (60 Gy and UFT/l-leukovorin with increasing doses of weekly oxaliplatin) and subsequently 15 patients had surgery. Five-year PFS is 60.6% (23.3 – NR). CRT, chemoradiotherapy; LARC locally advanced rectal cancer; PFS, progression free survival.