Evidence map›Paper›PMID 30827001›Full record

Trial reportGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2019

Randomized phase III trial of gastrectomy with or without neoadjuvant S-1 plus cisplatin for type 4 or large type 3 gastric cancer, the short-term safety and surgical results: Japan Clinical Oncology Group Study (JCOG0501).

Masanori Terashima, Yoshiaki Iwasaki, Junki Mizusawa, Hiroshi Katayama, Kenichi Nakamura, Hitoshi Katai, Takaki Yoshikawa, Yuichi Ito, Masahide Kaji, Yutaka Kimura and 8 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 85 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
85citing papers in PubMed, 5 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

85 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Japanese gastric cancer treatment guidelines 2025 (7th edition).Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2026
    Guideline
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  6. Neoadjuvant docetaxel, oxaliplatin, and S-1 therapy for patients with large type 3 or type 4 gastric cancer: short-term outcomes of a multicenter, phase II study (OGSG1902).Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2025
    Trial
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  10. Phase II study of S-1 and oxaliplatin as neoadjuvant chemotherapy for locally advanced adenocarcinoma of the gastric or esophagogastric junction: KSCC1601.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2022
    Trial
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  12. Gastrectomy with or without neoadjuvant S-1 plus cisplatin for type 4 or large type 3 gastric cancer (JCOG0501): an open-label, phase 3, randomized controlled trial.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2021
    Trial
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  14. An integrated analysis of two phase II trials (JCOG0001 and JCOG0405) of preoperative chemotherapy followed by D3 gastrectomy for gastric cancer with extensive lymph node metastasis.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2019
    Trial
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25 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Masanori TerashimaDivision of Gastric Surgery, Shizuoka Cancer Center, 1007 Monagakubo, Nagaizumi-cho, Sunto-gun, Nagaizumi, Shizuoka, 411-8777, Japan. m.terashima@scchr.jp.ORCID http://orcid.org/0000-0002-2967-8267
Yoshiaki IwasakiDepartment of Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, Tokyo, Japan.
Junki MizusawaJCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Hiroshi KatayamaJCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Kenichi NakamuraJCOG Data Center/Operations Office, National Cancer Center Hospital, Tokyo, Japan.
Hitoshi KataiDepartment of Gastric Surgery, National Cancer Center Hospital, Tokyo, Japan.
Takaki YoshikawaDepartment of Gastrointestinal Surgery, Kanagawa Cancer Center Hospital, Yokohama, Japan.
Yuichi ItoDepartment of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.
Masahide KajiDepartment of Surgery, Toyama Prefectural Central Hospital, Toyama, Japan.
Yutaka KimuraDepartment of Surgery, Sakai City Hospital, Sakai, Japan.
Motohiro HiraoDepartment of Surgery, National Hospital Organization Osaka National Hospital, Osaka, Japan.
Makoto YamadaDepartment of Surgery, Gifu Municipal Hospital, Gifu, Japan.
Akira KuritaDepartment of Surgery, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.
Masakazu TakagiDepartment of Surgery, Shizuoka General Hospital, Shizuoka, Japan.
Narikazu BokuDepartment of Gastrointestinal Oncology, National Cancer Center Hospital, Tokyo, Japan.
Takeshi SanoDepartment of Gastroenterological Surgery, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Mitsuru SasakoDepartment of Surgery, Hyogo College of Medicine, Kobe, Japan.
Stomach Cancer Study Group, Japan Clinical Oncology Group

Funding

Ministry of Health, Labour and Welfare H19-15Ministry of Health, Labour and Welfare H22-027Ministry of Health, Labour and Welfare H22-23National Cancer Center Research and Development Fund 23-A-19National Cancer Center Research and Development Fund 26-A-4National Cancer Center Research and Development Fund 29-A-3
6 · The paper itself

Abstract

backgroundThe prognosis of patients with linitis plastica (type 4) and large (≥ 8 cm) ulcero-invasive-type (type 3) gastric cancer is extremely poor, even after extended surgery and adjuvant chemotherapy. Given the promising results of our previous phase II study evaluating neoadjuvant chemotherapy (NAC) with S-1 plus cisplatin (JCOG0210), we performed a phase III study to confirm the efficacy of NAC in these patients, with the safety and surgical results are presented here.

methodsEligible patients were randomized to gastrectomy plus adjuvant chemotherapy with S-1 (Arm A) or NAC followed by gastrectomy + adjuvant chemotherapy (Arm B). The primary endpoint was the overall survival (OS). This trial is registered at the UMIN Clinical Trials Registry as C000000279.

resultsFrom February 2007 to July 2013, 300 patients were randomized (Arm A 149, Arm B 151). NAC was completed in 133 patients (88%). Major grade 3/4 adverse events during NAC were neutropenia (29.3%), nausea (5.4%), diarrhea (4.8%), and fatigue (2.7%). Gastrectomy was performed in 147 patients (99%) in Arm A and 139 patients (92%) in Arm B. The operation time was significantly shorter in Arm B than in Arm A (median 255 vs. 240 min, respectively; p = 0.024). There were no significant differences in Grade 2-4 morbidity and mortality (25.2% and 1.3% in Arm A and 15.8% and 0.7% in Arm B, respectively).

conclusionsNAC for type 4 and large type 3 gastric cancer followed by D2 gastrectomy can be safely performed without increasing the morbidity or mortality.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsCisplatinCombined Modality TherapyDrug CombinationsFemaleFollow-Up StudiesGastrectomyHumansMaleMiddle AgedNeoadjuvant TherapyNeoplasm StagingOxonic AcidPeritoneal NeoplasmsCisplatinDrug CombinationsOxonic AcidS 1 (combination)TegafurLarge type 3Linitis plasticaNeoadjuvant chemotherapy

Identifiers

PMID30827001

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.