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

Authors

Kota Kawabata, Tsutomu Hayashi, Rie Makuuchi, Takanobu Yamada, Masayuki Yokoyama, Takeshi Uozumi, Noriko Mitome, Haruhiko Fukuda, Yukinori Kurokawa, Narikazu Boku, Takaki Yoshikawa

Published in

Japanese journal of clinical oncology. Aug 03, 2026. Epub Aug 03, 2026.

Abstract

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).

PMID:
42545799
Bibliographic data and abstract were imported from PubMed on 04 Aug 2026.

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