Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182611
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2005-09-15
Brief Title:
S-1 and Cisplatin in Treating Patients Who Are Undergoing Surgery for Stage III Stomach Cancer
Sponsor:
Kyoto University
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Clinical Study of Preoperative S-1CDDP Combination Chemotherapy in Patients With Potentially Resectable Stage III Advanced Gastric Cancer
Status:
COMPLETED
Status Verified Date:
2008-11
Last Known Status:
None
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 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
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
Detailed Description:
OBJECTIVES
Primary
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
Secondary
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
Primary
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
Secondary
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
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 |
|---|---|---|---|
| CDR0000426403 | REGISTRY | PDQ Physician Data Query | None |