Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
S-1 and Cisplatin Before Surgery in Treating Patients With Stage IV Gastric Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II | Treatment | Closed | 20 and over | Other | KYUH-UHA-GC03-01 NCT00088816 |
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.
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
- Stage IV disease meeting 1 of the following staging criteria according to Japanese gastric cancer classification:
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
50A total of 50 patients will be accrued for this study.
Outcomes
Primary Outcome(s)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 Lead Organizations
Kyoto University Hospital
 | | | ||
| Seiji Satoh, Protocol chair | |
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| Registry Information | ||
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| Official Title | Phase II Clinical Study of Preoperative S-1/CDDP Combination Chemotherapy in Patients with Advanced Gastric Cancer | |
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| Trial Start Date | 2003-04-01 | |
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| Trial Completion Date | 2008-03-31 (estimated) | |
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| Registered in ClinicalTrials.gov | NCT00088816 | |
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| Date Submitted to PDQ | 2004-04-23 | |
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| Information Last Verified | 2008-03-30 | |
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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