Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00088816
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
2004-08-04
Brief Title:
S-1 and Cisplatin Before Surgery in Treating Patients With Stage IV Gastric Cancer
Sponsor:
Kyoto University
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Clinical Study of Preoperative S-1CDDP Combination Chemotherapy in Patients With Advanced Gastric Cancer
Status:
UNKNOWN
Status Verified Date:
2008-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KYUH-UHA-GC03-01 | None | None | None |