A Trial of Neoadjuvant TS-1 and Cisplatin for Type 4 and Large Type 3 Gastric Cancer

Randomized Phase III Trial of Surgery Plus Neoadjuvant 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

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00252161

Enrollment

316

Registered

2005-11-11

Start date

2005-11-30

Completion date

2015-04-30

Last updated

2016-09-22

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

Conditions

Gastric Neoplasm

Keywords

Neoadjuvant Therapy, Stomach Neoplasms, Cisplatin, S-1(combination)

Brief summary

The aim of this study is to evaluate survival benefit of TS-1 plus cisplatin as a neoadjuvant chemotherapy in gastric cancer patient with resectable type 4 (linitis plastica type) and large type 3 tumor in comparison with surgery alone.

Detailed description

A randomized phase III study is going to started in Japan to compare TS-1 plus cisplatin as a neoadjuvant chemotherapy with surgery alone in patient with type 4 and large type 3 gastric cancer.A total of 300 patients will be accrued for this study from 35 institutions within five years. The primary endpoint is overall survival. The secondary endpoints are progression free survival (PFS), response rate, proportion of protocol achievement, proportion of curative resection, and adverse events.

Interventions

PROCEDUREGastrectomy with more than D2 dissection

Gastrectomy with more than D2 dissection

DRUGNeoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy

Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. histologically proven adenocarcinoma of stomach 2. Borrmann type 4 or large (\>=8 cm) type 3 3. no evidence of distant metastasis including liver(M0) 4. no evidence of para-aortic and/or retropancreatic lymph node metastasis(N0-2) 5. no peritoneal metastasis and negative peritoneal lavage cytology (PLS) with laparoscopic confirmation 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

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, intestinal pneumonitis, pulmonary fibrosis, or ischemic heart disease 6. myocardial infarction within six disease-free months

Design outcomes

Primary

Measure	Time frame
overall survival	during the study conduct

Secondary

Measure	Time frame
progression free survival (PFS)	during the study conduct
response rate	during the study conduct
proportion of protocol achievement	during the study conduct
proportion of curative resection	during the study conduct
adverse events	during the study conduct

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026