Status:
COMPLETED
S-1 and Cisplatin in Treating Patients Who Are Undergoing Surgery for Stage III Stomach Cancer
Lead Sponsor:
Kyoto University
Conditions:
Gastric Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as S-1 and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more t...
Detailed Description
OBJECTIVES: Primary * Compare the overall survival of patients with potentially resectable stage III gastric cancer treated with neoadjuvant S-1 and cisplatin followed by gastrectomy and adjuvant S-...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed gastric adenocarcinoma, including type II or type III adenocarcinoma of the esophagogastric junction
- Stage III disease
- T3 or T4 and/or N2
- No stage IV disease
- Helical CT scan and laparoscopic staging required
- Potentially resectable disease
- PATIENT CHARACTERISTICS:
- Age
- 20 and over
- Performance status
- ECOG 0-1
- Life expectancy
- Not specified
- Hematopoietic
- WBC ≥ 4,000/mm³, but \< 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
- Arterial oxygen pressure (PaO\_2) ≥ 70 mm Hg on room air
- Other
- Able to take oral medications
- 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 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2008
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00182611
Start Date
April 1 2004
End Date
November 1 2008
Last Update
June 26 2013
Active Locations (6)
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1
Fukui Red Cross Hospital
Fukui-shi, Fukui, Japan, 918-8501
2
Kyoto University Hospital
Kyoto, Kyoto, Japan, 606-8507
3
National Hospital Organization - Kyoto Medical Center
Kyoto, Kyoto, Japan, 612-0861
4
Yamato Municipal Hospital
Yamatotakada, Nara, Japan, 635-8501