S-1 and Cisplatin Before Surgery in Treating Patients With Stage IV Gastric Cancer

Phase 2

• Conditions: Gastric Cancer

• Registration Number: NCT00088816
• Lead Sponsor: Kyoto University

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as S-1 and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Giving combination chemotherapy before surgery may shrink the tumor so that it can be removed.

PURPOSE: This phase II trial is studying how well giving S-1 together with cisplatin works in treating patients who are undergoing surgery for stage IV gastric cancer.

Detailed Description

OBJECTIVES:

Primary

* Determine the efficacy and feasibility of neoadjuvant chemotherapy comprising S-1 and cisplatin in patients with stage IV gastric adenocarcinoma.

* Determine the overall survival of patients treated with this regimen.

Secondary

* Determine the time to progression and types of initial recurrence in patients treated with this regimen.

* Determine tumor response in patients treated with this regimen.

* Determine mortality and morbidity related to treatment in these patients.

* Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral S-1 on days 1-21 and cisplatin IV over 2 hours on day 8. Treatment repeats every 35 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo gastrectomy with lymphadenectomy. Patients resume oral S-1 after surgery.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2004-08-04
• Study First Submitted QC: 2004-08-04
• Study First Posted: 2004-08-05
• Status Verified: 2008-03
• Primary Completion: 2008-03
• Last Update Submitted: 2013-09-16
• Last Update Posted: 2013-09-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival

Secondary Outcome Measures

Name	Time	Method
Postoperative complications
Time to progression
Tumor response
Death related to treatment
Histological response
Surgical/pathological curative resection
Types of initial recurrence
Adverse events

Trial Locations

Locations (7)

Kyoto University Hospital; 🇯🇵 Kyoto, Japan

Kyoto-Katsura Hospital; 🇯🇵 Kyoto, Japan

National Hospital Organization - Kyoto Medical Center; 🇯🇵 Kyoto, Japan

Yamato Municipal Hospital; 🇯🇵 Yamato City Kanagawa, Japan

Kansai Denryoku Hospital; 🇯🇵 Osaka, Japan

Shimane Prefectural Central Hospital; 🇯🇵 Izumo-shi, Shimane, Japan

Kitano Hospital; 🇯🇵 Osaka, Japan