J.Jpn. Surg. Soc.. 125(2): 124-130, 2024

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Feature topic

RANDOMIZED, CONTROLLED TRIALS IN UPPER GASTROINTESTINAL SURGERY: THE ROAD TO TOP JOURNALS

Clinical trials of postoperative adjuvant chemotherapy for gastric cancer have been conducted since the 1960s, but no regimen with a confirmed survival benefit was established until the early 2000s. The first edition of the Gastric Cancer Treatment Guidelines in March 2001 stated that “postoperative adjuvant chemotherapy should be established through multicenter clinical trials.’’ The ACTS-GC trial (a phase III trial of S-1 vs. surgery alone for curatively resected stage II/III gastric cancer patients) started at the same time, enrolling 1,059 patients from 109 Japanese centers nationwide in a short period of time. An interim analysis in June 2006 demonstrated the efficacy and safety of the treatment group, and the trial was terminated early. In addition, the results of the trial were published in the New England Journal of Medicine in 2007, establishing the standard treatment for postoperative adjuvant chemotherapy for gastric cancer in Japan. In order for the results of a randomized, controlled trial to be accepted for publication in top-tier journals, it is important to develop a research design that is beneficial to a large number of patients, quickly accumulate cases, and perform rigorous statistical analysis. The most important factor is the cooperation among surgeons, physicians, and clinical research centers to ensure high-quality treatment.

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