کارآزمائی بالینی فازIII بررسی نقش دو روش شیمی درمانی قبل از عمل در ایجاد امکان جراحی کامل کارسینوم پیشرفته معده

Background: This prospective phase III study was designed to compare the activity of two combinations chemotherapy drugs in advanced gastric adenocarcinoma Methods: In a double blinded clinical trial, From Jan. 2002 to Jan. 2005, ninety patients with advanced gastric adenocarcinoma were randomly assigned to 1) Cisplatin and continuous infusion of 5FU and Epirubicin (ECF), and 2) Cisplatin and continuous infusion of 5FU with Docetaxel (TCF). Reduction in tumor mass, overall survival (OS), time to progression (TTP), and safety were measured outcome. Results: About 90% of patients had stage III or IV disease and the most common sites of tumor spread were peritoneal surfaces, liver and Paraaortic lymph nodes in either group. The objective clinical response rate (more than 50% decreases in tumor mass) was 38% and 43% in ECF and TCF group respectively. Global quality of life increased (p=0 002) and symptoms of pain and insomnia decreased after chemotherapy. Patients in TCF had more grade one or two skin reactions, neuropathy and diarrhea. Fourteen patients underwent surgery. Complete microscopic (R0) resection had done in two of ECF and six of TCF tumors (p=0.015). Two cases in TCF group showed complete pathologic response. Median TTP was nine months and 10 months in ECF and TCF group respectively. Median OS was 12 months in both groups. Conclusion: Although there wasn’t statistically significant difference regarded to clinical response or survival between two groups, TCF showed more complete pathologic response.