S-1 and Irinotecan in Treating Patients Who Are Undergoing Surgery for Locally Advanced Stomach Cancer
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|ClinicalTrials.gov Identifier: NCT00134095|
Recruitment Status : Unknown
Verified January 2010 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : August 24, 2005
Last Update Posted : September 17, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Gastric Cancer||Drug: irinotecan hydrochloride Drug: tegafur-gimeracil-oteracil potassium Procedure: adjuvant therapy Procedure: conventional surgery Procedure: neoadjuvant therapy||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Masking:||None (Open Label)|
|Official Title:||Phase II Clinical Study of Preoperative S-1/CPT-11 Combination Chemotherapy in Patients With Locally Advanced Gastric Cancer|
|Study Start Date :||September 2004|
|Actual Primary Completion Date :||August 2008|
- Tumor shrinkage
- Historical tumor shrinkage
- Overall survival
- Progression-free survival
- Median survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|