S-1 and Cisplatin Before Surgery in Treating Patients With Stage IV Gastric Cancer
Recruitment status was Active, not recruiting
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.
Drug: tegafur-gimeracil-oteracil potassium
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Clinical Study of Preoperative S-1/CDDP Combination Chemotherapy in Patients With Advanced Gastric Cancer|
- Overall survival [ Designated as safety issue: No ]
- Time to progression [ Designated as safety issue: No ]
- Tumor response [ Designated as safety issue: No ]
- Death related to treatment [ Designated as safety issue: No ]
- Histological response [ Designated as safety issue: No ]
- Postoperative complications [ Designated as safety issue: No ]
- Surgical/pathological curative resection [ Designated as safety issue: No ]
- Types of initial recurrence [ Designated as safety issue: No ]
- Adverse events [ Designated as safety issue: Yes ]
|Study Start Date:||April 2003|
|Estimated Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
- 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.
- 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.
|Shimane Prefectural Central Hospital|
|Izumo-shi, Shimane, Japan, 693-0068|
|Kyoto University Hospital|
|Kyoto, Japan, 606-8507|
|Kyoto, Japan, 615-8256|
|National Hospital Organization - Kyoto Medical Center|
|Kyoto, Japan, 612-0861|
|Kansai Denryoku Hospital|
|Osaka, Japan, 553-0003|
|Osaka, Japan, 530-8480|
|Yamato Municipal Hospital|
|Yamato City Kanagawa, Japan, 242-8602|
|Study Chair:||Seiji Satoh||Kyoto University|