A Phase III Randomized Controlled Trial of Adjuvant Chemotherapy for Gastric Adenocarcinoma: Mitomycin and Doxifluridine Versus Intraperitoneal Chemotherapy and Mitomycin, Doxifluridine, and Cisplatin
Stomach cancer is the most common cancer in Korea and one of the major health problems
worldwide. The most effective treatment for gastric cancer is curative surgical resection of
primary tumor. However, a substantial number of patients eventually die of recurrences after
curative resection. A number of randomized trials investigating the role of adjuvant
chemotherapy have been conducted. However, the efficacy of adjuvant chemotherapy is still
controversial and varied between Western and Asian trials. Meta-analysis of Western trials
didn't demonstrate the benefit of adjuvant chemotherapy after curative resection.
Conversely, some Asian studies have demonstrated the efficacy of adjuvant chemotherapy after
curative resection. In a previous study, mitomycin plus tegafur prolonged the survival in
resected gastric cancer compared to no treatment.
This study is designed to evaluate the efficacy of the intraperitoneal chemotherapy with
early mitomycin administration and adding cisplatin to prolonged treatment with
doxifluridine compared to mitomycin plus doxifluridine.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Yoon-Koo Kang, M.D.,Ph.D.
Asan Medical Center
South Korea: Korea Food and Drug Administration (KFDA)