Gastric Cancer Clinical Trial
Official title:
Phase II Clinical Study of Preoperative S-1/CDDP Combination Chemotherapy in Patients With Advanced Gastric Cancer
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 cells. Giving combination chemotherapy before surgery may shrink the tumor
so that it can be removed.
PURPOSE: This phase II trial is studying how well giving S-1 together with cisplatin works
in treating patients who are undergoing surgery for stage IV 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.
;
Masking: Open Label, Primary Purpose: Treatment
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