OBJECTIVETo evaluate the safety and efficacy of the united intraoperative (125)I seed implantation as a treatment option for thoracic advanced esophageal squamous cell carcinoma (ESCC).

METHODSFrom January 2000 to August 2004, according to preoperative CT staging criteria, 298 patients in phase II to III of ESCC had been enrolled in this prospective study. With informed consent, they were randomized into two groups: intraoperative (125)I seed implantation (group A) and surgery alone (group B). With 0.5 mCi of single seed, total activity in 10 to 30 mCi, matched peripheral dose in 60 to 70 Gy, 20 to 40 (125)I seeds were implanted into the target under direct vision in accordance with treatment planning system. The post-operative complications were observed. The validation and quality assessment of radioactive seeds were demonstrated according to CT scan or X imaging. The short-term efficacy was evaluated according to WHO criteria. The 1-, 3-, 5-, and 7-year survival rate were followed up.

RESULTSOn the close date of August 31st 2008, the satisfied quality assessment of (125)I seeds was observed. There was no displacement or loss of seed. The local recurrence rates in the group A and group B were 14.9% and 38.7%, respectively, which were statistically significant (P < 0.05). The complete response and partial response rate in the group A was 78.8%. It was significantly higher than 30.3% in the group B (P < 0.05). There was no statistical difference among groups when comparing the complications (P > 0.05). The 1-year survival rates were no statistical difference among the two groups. However, the 3-, 5-, and 7-year survival rates in group A (64.0%, 42.7%, and 25.1%) were statistically different from that in the B group (52.0%, 34.5%, and 12.6%) (P < 0.05).

CONCLUSIONSIt is safe, effective and simple application about the intraoperative (125)I seed implantation for advanced ESCC. It may reduce the local recurrence rate and improve survival.