Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2026-01-01 @ 3:37 PM
Study NCT ID:
NCT00134095
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
2005-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
S-1 and Irinotecan in Treating Patients Who Are Undergoing Surgery for Locally Advanced Stomach Cancer
Sponsor:
Fukushima Medical University Hospital
Organization:
Study Overview
Official Title:
Phase II Clinical Study of Preoperative S-1/CPT-11 Combination Chemotherapy in Patients With Locally Advanced Gastric Cancer
Status:
UNKNOWN
Status Verified Date:
2010-01
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 irinotecan, 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 completely removed.
PURPOSE: This phase II trial is studying how well giving S-1 together with irinotecan works in treating patients who are undergoing surgery for locally advanced stomach cancer.
PURPOSE: This phase II trial is studying how well giving S-1 together with irinotecan works in treating patients who are undergoing surgery for locally advanced stomach cancer.
Detailed Description:
OBJECTIVES:
Primary
* Determine the efficacy of neoadjuvant S-1 and irinotecan in patients with locally advanced gastric cancer.
Secondary
* Determine the histological response in patients treated with this regimen.
* Determine the overall survival of patients treated with this regimen.
* Determine the progression-free survival of patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
* Determine postoperative morbidity in patients treated with this regimen.
* Determine the rate of potentially curative surgery in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive oral S-1 on days 1-21 and irinotecan IV over 90 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo gastrectomy with lymphadenectomy. After surgery, patients resume treatment with S-1 alone as before for 1 year.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.
Primary
* Determine the efficacy of neoadjuvant S-1 and irinotecan in patients with locally advanced gastric cancer.
Secondary
* Determine the histological response in patients treated with this regimen.
* Determine the overall survival of patients treated with this regimen.
* Determine the progression-free survival of patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.
* Determine postoperative morbidity in patients treated with this regimen.
* Determine the rate of potentially curative surgery in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive oral S-1 on days 1-21 and irinotecan IV over 90 minutes on days 1 and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo gastrectomy with lymphadenectomy. After surgery, patients resume treatment with S-1 alone as before for 1 year.
PROJECTED ACCRUAL: A total of 70 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 ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| FMUH-UHA-GC04-02 | None | None | View |