A single-arm phase III trial evaluating the non-inferiority of less-intensive surveillance for early gastric cancer: JCOG2504 (less-surveillance EGC)

Le résumé fourni par la source

Patients with pathological stage I (pStage I) gastric cancer (GC) have a very low recurrence risk after curative resection. Nevertheless, intensive postoperative surveillance, similar to that for advanced disease, is widely practiced despite the unclear survival benefit. Previous studies have not demonstrated improved overall survival (OS) through early detection of asymptomatic recurrence; however, intensive surveillance may cause unnecessary radiation exposure, patient burdens, and increased healthcare costs. Therefore, evidence is needed to determine whether a less-intensive risk-adapted surveillance strategy is clinically acceptable for this low-risk population. We designed a single-arm phase III trial (JCOG2504) to confirm the non-inferiority of less-intensive surveillance compared to standard surveillance in patients with pStage I GC after curative resection. The primary endpoint is OS. A total of 605 patients from 66 institutions will be enrolled over 3 years. The trial has been registered in the Japan Registry of Clinical Trials (study number: jRCT1030250844).

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