S-1 and Cisplatin in Treating Patients Who Are Undergoing Surgery for Stage III Stomach Cancer
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 than one drug (combination chemotherapy) may kill more tumor cells. Giving chemotherapy before surgery may shrink the tumor so that it can be removed. It is not yet known whether giving S-1 together with cisplatin before surgery is more effective than surgery followed by S-1 in treating stomach cancer.
PURPOSE: This randomized phase III trial is studying how well giving S-1 together with cisplatin before surgery works compared to surgery followed by S-1 in treating patients with stage III stomach cancer.
Drug: tegafur-gimeracil-oteracil potassium
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Phase III Clinical Study of Preoperative S-1/CDDP Combination Chemotherapy in Patients With Potentially Resectable Stage III Advanced Gastric Cancer|
- Overall survival [ Designated as safety issue: No ]
- Progression-free survival (PFS) [ Designated as safety issue: No ]
- Postoperative PFS [ Designated as safety issue: No ]
- Surgical/pathological curative resection [ Designated as safety issue: No ]
- Death related to treatment [ Designated as safety issue: No ]
- Death related to operation [ Designated as safety issue: No ]
- Postoperative complications [ Designated as safety issue: No ]
- Adverse events [ Designated as safety issue: Yes ]
|Study Start Date:||April 2004|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
- 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-1 vs no neoadjuvant chemotherapy before gastrectomy and adjuvant S-1.
- Compare the progression-free survival of patients treated with these regimens.
- Compare the curative resection rates in patients treated with these regimens.
- Compare the safety of these regimens, in terms of postoperative complications, adverse events, and treatment- or surgery-related mortality rate, in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (T3 vs T4) and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms.
- Arm I (control): Patients undergo gastrectomy with D2+ lymph node dissection. Patients then receive adjuvant oral S-1.
- Arm II (neoadjuvant therapy): Patients receive neoadjuvant 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. Patients then undergo surgery and receive adjuvant S-1 as in arm I.
PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.
|Yamato Municipal Hospital|
|Yamatotakada, Nara, Japan, 635-8501|
|Shimane Prefectural Central Hospital|
|Izumo-shi, Shimane, Japan, 693-0068|
|Fukui Red Cross Hospital|
|Fukui, Japan, 918-8501|
|National Hospital Organization - Kyoto Medical Center|
|Kyoto, Japan, 612-0861|
|Kyoto University Hospital|
|Kyoto, Japan, 606-8507|
|Osaka, Japan, 530-8480|
|Study Chair:||Seiji Satoh||Kyoto University|