Phase II Clinical Study of Preoperative S-1/CDDP Combination Chemotherapy in Patients With Advanced Gastric Cancer
20 Years
N/A
Both
Gastric Cancer
Trial Information
Phase II Clinical Study of Preoperative S-1/CDDP Combination Chemotherapy in Patients With Advanced Gastric Cancer
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.
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.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Inclusion 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
PATIENT CHARACTERISTICS:
Age
- 20 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- WBC ≥ 4,000/mm^3 AND < 12,000/mm^3
- Granulocyte count ≥ 2,000/mm^3
- Platelet count ≥ 100,000/mm^3
- 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
- PaO_2 ≥ 70 mm Hg on room air
Other
- Able to swallow oral medication
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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall survival
Safety Issue:
No
Principal Investigator
Seiji Satoh
Investigator Role:
Study Chair
Investigator Affiliation:
Kyoto University
Authority:
United States: Federal Government
Study ID:
CDR0000368443
NCT ID:
NCT00088816
Start Date:
April 2003
Completion Date:
Related Keywords:
- Gastric Cancer
- stage IV gastric cancer
- adenocarcinoma of the stomach
- Stomach Neoplasms
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