S-1 and Irinotecan in Treating Patients Who Are Undergoing Surgery for Locally Advanced Stomach Cancer
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.
Drug: irinotecan hydrochloride
Drug: tegafur-gimeracil-oteracil potassium
Procedure: adjuvant therapy
Procedure: conventional surgery
Procedure: neoadjuvant therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Clinical Study of Preoperative S-1/CPT-11 Combination Chemotherapy in Patients With Locally Advanced Gastric Cancer|
- Tumor shrinkage [ Designated as safety issue: No ]
- Historical tumor shrinkage [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
- Median survival [ Designated as safety issue: No ]
- Safety [ Designated as safety issue: Yes ]
|Study Start Date:||September 2004|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
- Determine the efficacy of neoadjuvant S-1 and irinotecan in patients with locally advanced gastric cancer.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00134095
|Yamamoto Kumiai General Hospital|
|Noshiro, Akita, Japan, 016-0014|
|Asahikawa Kosei General Hospital|
|Asahikawa, Hokkaido, Japan, 078-8211|
|Kobe City General Hospital|
|Kobe, Hyogo, Japan, 650|
|Iwate Medical University Hospital|
|Morioka, Iwate, Japan, 020-8505|
|Tsuruoka Municipal Shonai Hospital|
|Tsuruoka, Yamagata, Japan, 997-8515|
|Fukushima Medical University Hospital|
|Fukushima, Japan, 960-1295|
|Yamagata Prefectural Central Hospital|
|Yamagata, Japan, 990-2292|
|Study Chair:||Mitsukazu Gotoh, MD||Fukushima Medical University Hospital|