S-1 and Cisplatin Before Surgery in Treating Patients With Stage IV Gastric Cancer
NCT ID: NCT00088816
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
50 participants
INTERVENTIONAL
2003-04-30
Brief Summary
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PURPOSE: This phase II trial is studying how well giving S-1 together with cisplatin works in treating patients who are undergoing surgery for stage IV gastric cancer.
Detailed Description
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Primary
* Determine the efficacy and feasibility of neoadjuvant chemotherapy comprising S-1 and cisplatin in patients with stage IV gastric adenocarcinoma.
* Determine the overall survival of patients treated with this regimen.
Secondary
* Determine the time to progression and types of initial recurrence in patients treated with this regimen.
* Determine tumor response in patients treated with this regimen.
* Determine mortality and morbidity related to treatment in these patients.
* Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral S-1 on days 1-21 and cisplatin IV over 2 hours on day 8. Treatment repeats every 35 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo gastrectomy with lymphadenectomy. Patients resume oral S-1 after surgery.
PROJECTED ACCRUAL: A total of 50 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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cisplatin
tegafur-gimeracil-oteracil potassium
adjuvant therapy
conventional surgery
neoadjuvant therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed gastric adenocarcinoma
* Stage IV disease meeting 1 of the following staging criteria according to Japanese gastric cancer classification:
* T4, N2
* T4, N3
* P1, CY1
* CT scan and laparoscopic staging required
PATIENT CHARACTERISTICS:
Age
* 20 and over
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* WBC ≥ 4,000/mm\^3 AND \< 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 ≤ 2.5 times upper limit of normal
* Bilirubin ≤ 1.5 mg/dL
Renal
* Creatinine clearance ≥ 50 mL/min
Pulmonary
* PaO\_2 ≥ 70 mm Hg on room air
Other
* Able to swallow oral medication
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy for gastric cancer
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy for gastric cancer
Surgery
* No prior surgery for gastric cancer
Other
* No other prior therapy for gastric cancer
20 Years
ALL
No
Sponsors
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Kyoto University
OTHER
Principal Investigators
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Seiji Satoh
Role: STUDY_CHAIR
Kyoto University Hospital
Locations
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Kyoto University Hospital
Kyoto, Kyoto, Japan
National Hospital Organization - Kyoto Medical Center
Kyoto, Kyoto, Japan
Kyoto-Katsura Hospital
Kyoto, Kyoto, Japan
Kitano Hospital
Osaka, Osaka, Japan
Kansai Denryoku Hospital
Osaka, Osaka, Japan
Shimane Prefectural Central Hospital
Izumo-shi, Shimane, Japan
Yamato Municipal Hospital
Yamato City Kanagawa, , Japan
Countries
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References
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Satoh S, Okabe H, Teramukai S, Hasegawa S, Ozaki N, Ueda S, Tsuji A, Sakabayashi S, Fukushima M, Sakai Y. Phase II trial of combined treatment consisting of preoperative S-1 plus cisplatin followed by gastrectomy and postoperative S-1 for stage IV gastric cancer. Gastric Cancer. 2012 Jan;15(1):61-9. doi: 10.1007/s10120-011-0066-9. Epub 2011 Jun 11.
Other Identifiers
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KYUH-UHA-GC03-01
Identifier Type: -
Identifier Source: secondary_id
CDR0000368443
Identifier Type: -
Identifier Source: org_study_id