Palliative superselective intra-arterial chemotherapy for advanced nonresectable gastric cancer.

From November 1988 to May 1996, a prospective randomized study was undertaken to assess the efficacy of superselective intra-arterial chemotherapy for surgically proved unresectable gastric carcinoma. Each patient had undergone endoscopy as well as abdominal and pelvic CT scanning for staging. Patients with evidence of liver metastasis, peritoneal carcinomatosis, enlarged retroperitoneal lymph nodes, or locally advanced disease beyond curative resection were excluded from the study. A total of 386 patients with potentially curable disease were randomized to one of three treatment groups: (1) control; (2) systemic intravenous chemotherapy; or (3) superselective intra-arterial chemotherapy. On completion of preoperative chemotherapy, all patients underwent operative exploration with curative intent. A total of 74 consecutive patients were found to be unresectable, as evidenced by the presence of liver metastasis, peritoneal carcinomatosis, enlarged retroperitoneal lymph nodes, or locally extensive disease not detected by preoperative CT scanning. The median survival time in the control group and after intravenous chemotherapy was only 91 and 96 days, respectively, as compared to 401 days in the patients receiving intra-arterial chemotherapy. The results confirmed that superselective intra-arterial chemotherapy conferred a highly significant survival advantage compared to control or systemic intravenous chemotherapy adjusted for all patient characteristics (P <0.0001).

RCT Entities:   Population Interventions Outcomes