NCT00088816

S-1 and Cisplatin Before Surgery in Treating Patients With Stage IV Gastric Cancer

Phase II Clinical Study of Preoperative S-1/CDDP Combination Chemotherapy in Patients With Advanced Gastric Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Kyoto University · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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 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.

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 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.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	tegafur-gimeracil-oteracil potassium
PROCEDURE	adjuvant therapy
PROCEDURE	conventional surgery
PROCEDURE	neoadjuvant therapy

Timeline

• Start date: 2003-04-01
• Primary completion: 2008-03-01
• First posted: 2004-08-05
• Last updated: 2013-09-17

Locations

7 sites across 1 country: Japan