[Results of intraperitoneal active charcoal-mitomycin C therapy of stomach carcinoma with serosa invasion].

Patients with gastric carcinoma and serosal invasion were randomized into a "treatment" or "control" protocol after R0 resection ("prophylactic group", n = 45) or palliative resection without cytoreductive surgery in cases with localized peritoneal seeding ("therapy group", n = 19). The results of a planned interim analysis after 5 years indicate that MMC-CH therapy causes little systemic toxicity but enhances the rate of intraabdominal infections (9/33 vs. 2/31, p < 0.01) and reoperations (5/33 vs 0/31, p < 0.05). The preliminary survival analysis shows a possible prognostic effect following R0 resection after 24 months (p < 0.05) and 36 months (p < 0.07), but no benefit for the palliative procedures, which caused the withdrawal of the "therapy" study arm.

RCT Entities:   Population Interventions Outcomes