كموراديوتراپي پيش از ازوفاژكتومي ترانس هياتال در مبتلايان به كارسينوم سلول سنگفرشي مري-پيش مطالعه باليني غيرتصادفي مرحله 1 در بيمارستان امام خميني (ره) تبريز

Chemoradiotherapy before Transhiatal Esophagectomy for Esophageal Squamous Cell Carcinoma - a Pilot Phase I Nonrandomized Clinical Trial in Tabriz Imam Khomeini Hospital

Background and objectives: With promising results from several institutions, many centers began to treat patients with esophageal squamous cell carcinoma (SCC) with neoadjuvant chemoradiotherapy followed by esophagectomy. The aim of this research is to determine the feasibility of this method in our selected patients. Materials and Methods: In this prospective phase I clinical trial, 10 patients (7 male, 3 female; 58.4±2.5 Y/O) with stage III and VIA lower thoracic esophageal SCC, were treated with intravenous infusion of 1000mg/m2/day 5-flourouracil during day 1 to 4, 75 mg/m2 cisplatin in day 1, and a total dose of 18 Gray external beam radiation during day 1 to 6 and underwent transhiatal esophagectomy during day 7 till 10. This group was compared with a retrospective group of 61 patients which treated with surgery alone. Age, sex, duration and grading of the dysphagea, differentiation and staging of the tumor were not different in these two groups. Results: There is no complete pathologic response in the study group. One patient died because of severe leukopenia and sepsis and other because of azygos vein rupture. Other complications were: chylothorax which required later thoracotomy (10%), recurrent nerve paresis (10%), superficial wound infection of the neck incision (10%). All patients had mild to moderate leukopenia (2600±400/mm3) during days 11 to 16. Total postoperative intensive care unit stay was 2.2±0.5 days and postoperative hospitalization was 15.7±1.8 days and in-hospital operative mortality was 20% and total morbidity was 50% which were not significantly different from control group (p<0.05).Postoperative blood transfusion was 5.3±0.8 unit per patient which was significantly greater than control group(P<0.05). Conclusion: The perioperative mortality and morbidity of this neoadjuvant protocol is acceptable comparing with our control group and we can propose phase II and III studies for determining the long-term effect of these protocol.