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

Alternate Title

S-1 and Cisplatin in Treating Patients Who Are Undergoing Surgery for Stage III Stomach Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active 20 and over Other KYUH-UHA-GC04-03 NCT00182611

Objectives

Primary

1. Compare the overall survival of patients with potentially resectable stage III gastric cancer treated with neoadjuvant S-1 and cisplatin followed by gastrectomy and adjuvant S-1 vs no neoadjuvant chemotherapy before gastrectomy and adjuvant S-1.

Secondary

1. Compare the progression-free survival of patients treated with these regimens.
2. Compare the curative resection rates in patients treated with these regimens.
3. Compare the safety of these regimens, in terms of postoperative complications, adverse events, and treatment- or surgery-related mortality rate, in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed gastric adenocarcinoma, including type II or type III adenocarcinoma of the esophagogastric junction
  • Stage III disease
    • T3 or T4 and/or N2
      • No stage IV disease
  • Helical CT scan and laparoscopic staging required



• Potentially resectable disease

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, but < 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

• Arterial oxygen pressure (PaO₂) ≥ 70 mm Hg on room air

Other

• Able to take oral medications

Expected Enrollment

A total of 100 patients (50 per treatment arm) will be accrued for this study.

Outcomes

Overall survival

Progression-free survival (PFS)
Postoperative PFS
Surgical/pathological curative resection
Death related to treatment
Death related to operation
Postoperative complications
Adverse events

Outline

This is a randomized, multicenter study. Patients are stratified according to disease stage (T3 vs T4) and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms.

• Arm I (control): Patients undergo gastrectomy with D2+ lymph node dissection. Patients then receive adjuvant oral S-1.



• Arm II (neoadjuvant therapy): Patients receive neoadjuvant 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. Patients then undergo surgery and receive adjuvant S-1 as in arm I.

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
Fukui
	Fukui
	Fukui Red Cross Hospital
		Yuki Hirose, MD	Ph:  81-776-36-3630
Kyoto
	Kyoto
	Kyoto University Hospital
		Seiji Satoh	Ph:  81-75-751-3234
			Email: sesami@kuhp.kyoto-u.ac.jp
	National Hospital Organization - Kyoto Medical Center
		Hiroaki Hata, MD	Ph:  81-75-641-9161
Nara
	Yamatotakada
	Yamato Municipal Hospital
		Ryuji Okamura, MD	Ph:  81-74-553-2901
Osaka
	Osaka
	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 III Clinical Study of Preoperative S-1/CDDP Combination Chemotherapy in Patients with Potentially Resectable Stage III Advanced Gastric Cancer
Trial Start Date		2004-04-01
Trial Completion Date		2009-03-31 (estimated)
Registered in ClinicalTrials.gov		NCT00182611
Date Submitted to PDQ		2005-03-14
Information Last Verified		2008-03-30

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