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

Alternate Title

S-1 and Irinotecan in Treating Patients Who Are Undergoing Surgery for Locally Advanced Stomach Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	20 to 75	Other	FMUH-UHA-GC04-02 NCT00134095, NCT00134095

Objectives

Primary

1. Determine the efficacy of neoadjuvant S-1 and irinotecan in patients with locally advanced gastric cancer.

Secondary

1. Determine the histological response in patients treated with this regimen.
2. Determine the overall survival of patients treated with this regimen.
3. Determine the progression-free survival of patients treated with this regimen.
4. Determine the toxicity of this regimen in these patients.
5. Determine postoperative morbidity in patients treated with this regimen.
6. Determine the rate of potentially curative surgery in patients treated with this regimen.

Entry Criteria

Disease Characteristics:

• Histologically confirmed gastric adenocarcinoma
  • Locally advanced disease
    • Clinical stage T3-4, N0-3, M0 (according to the Japanese gastric cancer classification)
• Planning to undergo curative surgery after neoadjuvant chemotherapy

Prior/Concurrent Therapy:

Biologic therapy

• No prior biologic therapy for gastric cancer

Chemotherapy

• No prior chemotherapy for gastric cancer

Endocrine therapy

• No prior endocrine therapy for gastric cancer

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 to 75

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

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

Hepatic

• AST and ALT ≤ 100 U/L
• Bilirubin ≤ 1.5 mg/dL

Renal

• Creatinine normal

  OR

• Creatinine clearance ≥ 50 mL/min

Pulmonary

• PaO₂ > 60 mm Hg on room air

Other

• Able to swallow oral medication

Expected Enrollment

A total of 70 patients will be accrued for this study.

Outcomes

Tumor shrinkage
Historical tumor shrinkage
Overall survival
Progression-free survival
Median survival
Safety

Outline

This is a multicenter study.

Patients receive oral S-1 on days 1-21 and irinotecan IV over 90 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo gastrectomy with lymphadenectomy. After surgery, patients resume treatment with S-1 alone as before for 1 year.

Trial Contact Information

Trial Lead Organizations

Fukushima Medical University Hospital

Mitsukazu Gotoh, MD, Protocol chair		Ph: 81-24-547-1252 Email: mgotoh@fmu.ac.jp

Registry Information
Official Title		Phase II Clinical Study of Preoperative S-1/CPT-11 Combination Chemotherapy in Patients With Locally Advanced Gastric Cancer
Trial Start Date		2004-09-01
Trial Completion Date		2008-08-30
Registered in ClinicalTrials.gov		NCT00134095NCT00134095
Date Submitted to PDQ		2005-06-28
Information Last Verified		2008-03-30

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