Background & objective: Although concurrent radiochemotherapy is popularly accepted as a standard treatment for advanced esophageal carcinoma, there is still great room to improve the clinical efficacy. This phase II clinical trial was to further verify the efficacy of sodium glyci-didazole (CM-Na), as a valid sensitizer, combined with concurrent radiochemotherapy on advanced esophageal carcinoma, and observe adverse events.
Methods: A total of 37 patients with esophageal carcinoma received radiotherapy at a dose of 54-60 Gy to the gross tumor volume (GTV) and a course of PF regimen [continuous intravenous drip of cisplatin 20 mg x (m(2) x d) g(-1) and 5-fluorouracil (5-FU) 500 mg x (m(2) x d) g(-1) on Days 1-5] every 3 weeks. All patients were given intravenous drip of CM-Na 700 mg/m(2) at 1 h before irradiation or chemotherapy three times weekly.
Results: All patients completed the treatment. Three months after treatment, 16 (43.2%) patients achieved complete remission (CR) and 17 (46.0%) achieved partial remission (PR); the overall response rate was 89.2%. The 1-and 2-year survival rates were 78.6% and 48.7%. The median survival time was 23.2 months. The occurrence rate of grade III adverse events was 21.6%; no neurotoxicity was observed.
Conclusion: Concurrent chemoradiotherapy combined with CM-Na could enhance the response rate and prolong survival of the patients with advanced esophageal carcinoma.