Phase III study on late course accelerated fractionated irradiation combined with concurrent chemotherapy for esophagus squamous cell carcinoma

Objective: To evaluate the role of late course accelerated fractionated irradiation (LCAF) combined with concurrent chemotherapy in the management of esophageal carcinoma. Methods: From March 1998 to July 2000, 111 eligible patients were randomized into LCAF alone group (LCAF, 57 patients) or LCAF plus concurrent chemotherapy group (LACF-CT, 54 patients). The radiotherapy regimen was identical in the two groups, consisting of conventional fractionation in the first 2/3 course and accelerated fractionation in the second 1/ 3 course to a total dose of 68.4 Gy/41 Fx/44 d. Chemotherapy regimen consisted of four cycles of cisplatin 25 mg/(m2·d) plus fluorouracil 600 mb/( m2·d) on day 1 to 3 every 4 weeks and was delivered on the first day of radiotherapy. Results: The median follow-up time was 67.1 months(range 47.6-76.4 months). The 1-,3-, 5- year survival rate was 67%, 44% , 40% and 77%, 39% 28% in LACF-CT and LCAF group, respectively (P=0.310). Grade 3 + 4 acute side-effect was 42% and 25% in LCAF-CT and LCAF group, respectively(P < 0. 05), with 3 treatment-related deaths in the LCAF-CT group. Conclusions: Late course accelerated fractionated irradiation combined with concurrent chemotherapy has a trend towards improving the survival, at the cost of increasing acute side-effect. Its role needs further confirmation by larger sample studied in randomization. (authors)