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

Phase 3

Completed

• Conditions: Gastric Neoplasm
• Interventions: Drug: Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy; Procedure: Gastrectomy with more than D2 dissection

• Registration Number: NCT00252161
• Lead Sponsor: Haruhiko Fukuda

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.

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-11-10
• Study First Submitted QC: 2005-11-10
• Study First Posted: 2005-11-11
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 316

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy	Drug: Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy
1	Gastrectomy with more than D2 dissection	Procedure/Surgery: Gastrectomy with more than D2 dissection

Primary Outcome Measures

Name	Time	Method
overall survival	during the study conduct

Secondary Outcome Measures

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

Trial Locations

Locations (35)

Aichi Cancer Center Hospital; 🇯🇵 Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan

Fujita Health University; 🇯🇵 Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi, Japan

National Cancer Center Hospital East; 🇯🇵 Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan

National Hospital Organization Shikoku Cancer Center; 🇯🇵 Matsuyama,Horinouchi,13, Ehime, Japan

Gifu Municipal Hospital; 🇯🇵 Gifu,Kashima-cho,7-1, Gifu, Japan

Hiroshima City Hospital; 🇯🇵 Hiroshima,Naka-ku,Motomachi,7-33, Hiroshima, Japan

Itami City Hospital; 🇯🇵 Itami,Koyaike,1-100, Hyogo, Japan

Iwate Medical University; 🇯🇵 Morioka,Uchimaru,19-1, Iwate, Japan

Kagoshima University,Faculty of Medicine; 🇯🇵 Kagoshima,Sakuragaoka,8-35-1, Kagoshima, Japan

Kanagawa Cancer Center; 🇯🇵 Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, Japan

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