Indications for early postoperative intraperitoneal chemotherapy of advanced gastric cancer: results of a prospective randomized trial.

Previous analysis of this prospective randomized trial and meta-analysis of published randomized trials of adjuvant intraperitoneal chemotherapy demonstrated improved survival in patients with advanced gastric cancer. Simple criteria applicable at the time of surgery for patient selection were sought in this analysis. From 1990 to 1995 a series of 248 patients with biopsy-proven gastric cancer were randomized intraoperatively to receive early postoperative intraperitoneal mitomycin C and 5-fluorouracil (125 patients) versus surgery only (123 patients). Gastric resection plus early postoperative intraperitoneal chemotherapy showed improved overall survival compared to surgery only (54% and 38%, respectively; p = 0.0278). There were statistically significant differences in patients with stage III (57% and 23%, respectively; p = 0.0024) and in those with stage IV (28% and 5%, respectively; p = 0.0098) gastric cancer. The improvement in survival rate was statistically significant for the subgroup of patients with gross serosal invasion (52% and 25%, respectively; p = 0.0004) and patients with lymph node metastasis (46% and 22%, respectively; p = 0.0027). The surgeons' impression about lymph node status was unreliable, but assessment of serosal invasion was accurate in 80% of cases. Gross serosal invasion with or without frozen section evaluation of lymph nodes can be used as the major selection criteria for early postoperative intraperitoneal chemotherapy of advanced gastric cancer.

RCT Entities:   Population Interventions Outcomes