S-1 and Irinotecan in Treating Patients Who Are Undergoing Surgery for Locally Advanced Stomach Cancer
NCT ID: NCT00134095
Last Updated: 2013-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
70 participants
INTERVENTIONAL
2004-09-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
NONE
Interventions
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irinotecan hydrochloride
tegafur-gimeracil-oteracil potassium
adjuvant therapy
conventional surgery
neoadjuvant therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed gastric adenocarcinoma
* Locally advanced disease
* Clinical stage T3-4, N0-3, M0 (according to the Japanese gastric cancer classification)
* Planning to undergo curative surgery after neoadjuvant chemotherapy
PATIENT CHARACTERISTICS:
Age
* 20 to 75
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* WBC 4,000-12,000/mm\^3
* Granulocyte count ≥ 2,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9.0 g/dL
Hepatic
* AST and ALT ≤ 100 U/L
* Bilirubin ≤ 1.5 mg/dL
Renal
* Creatinine normal OR
* Creatinine clearance ≥ 50 mL/min
Pulmonary
* PaO\_2 \> 60 mm Hg on room air
Other
* Able to swallow oral medication
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior biologic therapy for gastric cancer
Chemotherapy
* No prior chemotherapy for gastric cancer
Endocrine therapy
* No prior endocrine therapy for gastric cancer
Radiotherapy
* No prior radiotherapy for gastric cancer
Surgery
* No prior surgery for gastric cancer
Other
* No other prior therapy for gastric cancer
20 Years
75 Years
ALL
No
Sponsors
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Fukushima Medical University Hospital
OTHER
Principal Investigators
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Mitsukazu Gotoh, MD
Role: STUDY_CHAIR
Fukushima Medical University Hospital
Locations
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Yamamoto Kumiai General Hospital
Noshiro, Akita, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan
Asahikawa Kosei General Hospital
Asahikawa, Hokkaido, Japan
Kobe City General Hospital
Kobe, Hyōgo, Japan
Iwate Medical University Hospital
Morioka, Iwate, Japan
Tsuruoka Municipal Shonai Hospital
Tsuruoka, Yamagata, Japan
Yamagata Prefectural Central Hospital
Yamagata, Yamagata, Japan
Countries
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Other Identifiers
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FMUH-UHA-GC04-02
Identifier Type: -
Identifier Source: secondary_id
CDR0000439474
Identifier Type: -
Identifier Source: org_study_id