Overview

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

Status:
Completed

Trial end date:
2015-04-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Haruhiko Fukuda

Collaborator:

Ministry of Health, Labour and Welfare, Japan

Treatments:

Cisplatin

Criteria

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