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)

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.

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.

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