Status:
UNKNOWN
S-1 and Cisplatin Before Surgery in Treating Patients With Stage IV Gastric Cancer
Lead Sponsor:
Kyoto University
Conditions:
Gastric Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as S-1 and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor...
Detailed Description
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 surviv...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00088816
Start Date
April 1 2003
Last Update
September 17 2013
Active Locations (7)
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1
Kyoto University Hospital
Kyoto, Kyoto, Japan, 606-8507
2
National Hospital Organization - Kyoto Medical Center
Kyoto, Kyoto, Japan, 612-0861
3
Kyoto-Katsura Hospital
Kyoto, Kyoto, Japan, 615-8256
4
Kitano Hospital
Osaka, Osaka, Japan, 530-8480