Randomized phase III trial of surgery plus neoadjubant TS-1 and cisplatin compared with surgery alone for type 4 and large type 3 gastric cancer: Japan Clinical Oncology Group Study (JCOG 0501)

Randomized phase III trial of surgery plus neoadjubant TS-1 and cisplatin compared with surgery alone for type 4 and large type 3 gastric cancer: Japan Clinical Oncology Group Study (JCOG 0501) - Randomized phase III trial of surgery plus neoadjubant TS-1 and cisplatin compared with surgery alone for type 4 and large type 3 gastric cancer: Japan Clinical Oncology Group Study (JCOG 0501)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000279

Enrollment

316

Registered

2005-11-08

Start date

2005-10-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

gastric neoplasm

Interventions

Gastrectomy with more than D2 disseciton + adjuvant chemotherpy(TS-1) Neoadjubant chemotherpy(TS-1+CDDP) followed by gastrectomy + adjuvant chemotherpy(TS-1)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) histologically proven adenocarcionoma of stomach (2) Borrmann type 4 or large (>=8 cm) type 3 (3) no evidence of distant metastasis including liver(M0) (4) macroscopic curative resection is judged as possible (5) no evidence of a macroscopic unresectable factor with laparoscopic confirmation. Dissemination to peritoneal surfaces adjacent to stomach (above the transverse colon, including omentum) and/or positive peritoneal lavage cytology is eligible. (6) no involvement of the esophagus with > 3cm (7) an age of 20-75 years (8) an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 (9) no prior chemotherapy, radiotherapy for any malignancy (10) no prior surgery for gastric cancer except for endoscopic membrane resection (EMR) (11) no breeding from primary tumor or gastrointestinal stenosis (12) sufficient oral intake (13) adequate organ function (14) written informed consent

Exclusion criteria

Exclusion criteria: (1) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ (2) pregnant or breast-feeding women (3) severe mental disease (4) systemic administration of corticosteroids, flucytosine, phenytoin or warfarin (5) other severe complications such as paralytic ileus, intensitinal pneumonitis, pulumonary fibrosis, or ischemic heart disease (6) myocardial infarction within six disease-free months (7) positive HBs antigen

Design outcomes

Primary

Measure	Time frame
overall survival	—

Secondary

Measure	Time frame
progression free survival (PFS), response rate, proportion of protocol achievement, proportion of curative resection, and adverse events. In this trial, curative resection means R0 resection (TNM classification) with more than D2 dissection.	—

Countries

Japan

Contacts

Public ContactYoshiaki Iwasaki, MD, PhD.

JCOG0501 Coordinating Office Department of Surgery, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

JCOG_sir@ml.jcog.jp03-3823-2101

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026