Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active 20 and over Other KYUH-UHA-GC03-01 NCT00088816

Objectives

Primary

1. Determine the efficacy and feasibility of neoadjuvant chemotherapy comprising S-1 and cisplatin in patients with stage IV gastric adenocarcinoma.
2. Determine the overall survival of patients treated with this regimen.

Secondary

1. Determine the time to progression and types of initial recurrence in patients treated with this regimen.
2. Determine tumor response in patients treated with this regimen.
3. Determine mortality and morbidity related to treatment in these patients.
4. Determine the toxicity of this regimen in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed gastric adenocarcinoma
  • Stage IV disease meeting 1 of the following staging criteria according to Japanese gastric cancer classification:
    • T4, N2
    • T4, N3
    • P1, CY1
  • CT scan and laparoscopic staging required

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for gastric cancer

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy for gastric cancer

Surgery

• No prior surgery for gastric cancer

Other

• No other prior therapy for gastric cancer

Patient Characteristics:

Age

• 20 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• WBC ≥ 4,000/mm³ AND < 12,000/mm³
• Granulocyte count ≥ 2,000/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9.0 g/dL

Hepatic

• AST and ALT ≤ 2.5 times upper limit of normal
• Bilirubin ≤ 1.5 mg/dL

Renal

• Creatinine clearance ≥ 50 mL/min

Pulmonary

• PaO₂ ≥ 70 mm Hg on room air

Other

• Able to swallow oral medication

Expected Enrollment

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

Outcomes

Overall survival

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

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.

Trial Contact Information

Trial Lead Organizations

Kyoto University Hospital

Seiji Satoh, Protocol chair		Ph: 81-75-751-3234 Email: sesami@kuhp.kyoto-u.ac.jp

Japan
	Yamato City Kanagawa
	Yamato Municipal Hospital
		Contact Person	Ph:  81-74-553-2901
			Email: ryuji-o@ym-hp.yamatotakada.nara.jp
Kyoto
	Kyoto
	Kyoto University Hospital
		Seiji Satoh	Ph:  81-75-751-3234
			Email: sesami@kuhp.kyoto-u.ac.jp
	Kyoto-Katsura Hospital
		Takemura Kazunori, MD	Ph:  81-75-391-5811
			Email: nfujita@katsura-hp.jp
	National Hospital Organization - Kyoto Medical Center
		Yoshiharu Sakai	Ph:  81-75-641-9161
			Email: ysakai@kyotolan.hosp.go.jp
Osaka
	Osaka
	Kansai Denryoku Hospital
		Ryuta Nishitai, MD, PhD	Ph:  81-6-6458-5821
			Email: k-21979@kepco.co.jp
	Kitano Hospital
		Arimichi Takabayashi	Ph:  81-6-6312-1221
			Email: atakaba@kitano-hp.or.jp
Shimane
	Izumo-shi
	Shimane Prefectural Central Hospital
		Nobuhiro Ozaki	Ph:  81-853-22-5111
			Email: osaki@spch.izumo.shimane.jp

Registry Information
Official Title		Phase II Clinical Study of Preoperative S-1/CDDP Combination Chemotherapy in Patients with Advanced Gastric Cancer
Trial Start Date		2003-04-01
Trial Completion Date		2008-03-31 (estimated)
Registered in ClinicalTrials.gov		NCT00088816
Date Submitted to PDQ		2004-04-23
Information Last Verified		2008-03-30

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