S-1 and Irinotecan in Treating Patients Who Are Undergoing Surgery for Locally Advanced Stomach Cancer
- Conditions
- Gastric Cancer
- Registration Number
- NCT00134095
- Lead Sponsor
- Fukushima Medical University Hospital
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 70
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Historical tumor shrinkage Tumor shrinkage Overall survival Progression-free survival Median survival Safety
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
Kobe City General Hospital
🇯🇵Kobe, Hyogo, Japan
Yamamoto Kumiai General Hospital
🇯🇵Noshiro, Akita, Japan
Tsuruoka Municipal Shonai Hospital
🇯🇵Tsuruoka, Yamagata, Japan
Fukushima Medical University Hospital
🇯🇵Fukushima, Japan
Yamagata Prefectural Central Hospital
🇯🇵Yamagata, Japan
Asahikawa Kosei General Hospital
🇯🇵Asahikawa, Hokkaido, Japan
Iwate Medical University Hospital
🇯🇵Morioka, Iwate, Japan