Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
S-1 and Irinotecan in Treating Patients Who Are Undergoing Surgery for Locally Advanced Stomach Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Treatment | Closed | 20 to 75 | Other | FMUH-UHA-GC04-02 NCT00134095 |
Objectives
Primary
- Determine the efficacy of neoadjuvant S-1 and irinotecan in patients with locally advanced gastric cancer.
Secondary
- Determine the histological response in patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
- Determine the progression-free survival of patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine postoperative morbidity in patients treated with this regimen.
- 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)
- Locally advanced disease
- 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
Pulmonary
- PaO2 > 60 mm Hg on room air
Other
- Able to swallow oral medication
Expected Enrollment
70A total of 70 patients will be accrued for this study.
Outcomes
Primary Outcome(s)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 Lead Organizations
Fukushima Medical University Hospital
 | | | ||
| Mitsukazu Gotoh, MD, Protocol chair | |
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| Registry Information | ||
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| Official Title | Phase II Clinical Study of Preoperative S-1/CPT-11 Combination Chemotherapy in Patients With Locally Advanced Gastric Cancer | |
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| Trial Start Date | 2004-09-01 | |
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| Trial Completion Date | 2008-08-30 | |
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| Registered in ClinicalTrials.gov | NCT00134095 | |
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| Date Submitted to PDQ | 2005-06-28 | |
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| Information Last Verified | 2010-01-19 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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