Study Results
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Basic Information
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COMPLETED
PHASE2
300 participants
INTERVENTIONAL
2006-03-31
2011-03-31
Brief Summary
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Detailed Description
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Treatment: All the patients will be treated with S-1 at a dose of 80 mg/m2 b.i.d. for 4 weeks followed by 2 weeks rest. The treatment will be continued until the recurrence or 1 year after operation.
Primary endpoint: 3-years disease-free survival rate Secondary endpoint: 3-years overall survival rate and side effect (CTCAE v3.0) Evaluation of chemosensitivity test: The cutoff condition will be determined based on the accumulated data of CD-DST and mRNAs.
Hypothesis: The responder detected by CD-DST and/or TS, DPD mRNA will have a favorable survival outcome comparing with resistant cases.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
SINGLE
Study Groups
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1
S-1
S-1 capsule at a dose of 80 mg/m2 b.i.d. for 4 weeks followed by 2 weeks rest.
Interventions
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S-1
S-1 capsule at a dose of 80 mg/m2 b.i.d. for 4 weeks followed by 2 weeks rest.
Eligibility Criteria
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Inclusion Criteria
* PS (ECOG) 0 or 2
* D2 dissection, curability B or more
* surgical Stage IIIA and IIIB
* negative peritoneal cytology
* no previous radiotherapy, chemotherapy and hormone therapy
* possible peroral intake at 6 POW
* no severe surgical complication
* normal bone marrow, liver and renal function
* complete chemosensitivity test
* written informed consent
Exclusion Criteria
* contraindication for S-1
* history of drug allergy (grade 3)
* severe complication
* watery diarrhea
* pregnant
* scirrhous gastric cancer
* the other patients who was judged as inadequate for trial by doctor on duty
20 Years
80 Years
ALL
Yes
Sponsors
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Kitasato University
OTHER
Japan Clinical Cancer Research Organization
OTHER
Responsible Party
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Center of Comprehensive and Advanced Medicine, Keio University
Principal Investigators
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Tetsuro Kubota, Processor
Role: PRINCIPAL_INVESTIGATOR
Keio University Hospital
Locations
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Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Department of frontier surgery,Draduate school of medicine,Chiba University
Chiba, Chiba, Japan
Kyusyu University Faculty of Medical Sciences
Fukuoka, Fukuoka, Japan
Kyusyu Central Hospital of the Mutual Aid Association of Public School Teachers
Fukuoka, Fukuoka, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan
Gunma University Hospital
Maehashi, Gunma, Japan
Hakodate Goryoukaku Hopsital
Hakodate, Hokkaido, Japan
Hyogo Prefectural Awaji Hospital
Sumoto, Hyōgo, Japan
Ishikawa Prefectural Central Hospital
Kanazawa, Ishikawa-ken, Japan
Kanazawa Medical University Hospital
Kanazawa, Ishikawa-ken, Japan
Iwate Medical University Hospital
Morioka, Iwate, Japan
Department of surgical oncology and digestive surgery kagoshima university graduate school
Kagoshima, Kagoshima-ken, Japan
Nippon Medical School Second Hospital
Kawasaki, Kanagawa, Japan
St. Marianna University, School of Medicine
Kawasaki, Kanagawa, Japan
Kitazato University East Hospital
Sagamihara, Kanagawa, Japan
Faculty of Medical and Pharmaceutical Sciences Kumamoto University
Kumamoto, Kumamoto, Japan
Niigata Prefectural Cancer Center
Niigata, Niigata, Japan
Hirakata City Hospital
Hirakata, Osaka, Japan
Osaka Kita Japan Post Hospital
Osaka, Osaka, Japan
Osaka City University Graduate School of Medicine
Osaka, Osaka, Japan
Saiseikai Suita Hospital
Suita, Osaka, Japan
Osaka Medical College Hospital
Takatsuki, Osaka, Japan
Yao Municipal Hospital
Yao, Osaka, Japan
Saga Medical School Faculty of Medicine,Saga University
Saga, Saga-ken, Japan
Jichi Medical School Hospital
Shimono, Tochigi, Japan
Dokkyo University School of Medecine
Shimotsuga, Tochigi, Japan
Tochigi Cancer Center
Utsunomiya, Tochigi, Japan
Surugadai Nihon University Hospital
Chiyoda-ku, Tokyo, Japan
Tobu Chiiki Hospital
Katsushika-ku, Tokyo, Japan
Cancer Institute Hospital
Koto-ku, Tokyo, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, Japan
Nippon Medical School Tama Nagayama Hospital
Tama, Tokyo, Japan
Tottori University Faculty of Medicine
Yonago, Tottori, Japan
Kouseiren Takaoka Hospital
Takaoka, Toyama, Japan
Wakayama Prefectural Medical University Hospital
Wakayama, Wakayama, Japan
Kanagawa Prefectural Cancer Center
Kanagawa, Yokohama, Japan
Countries
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References
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Tanigawa N, Yamaue H, Ohyama S, Sakuramoto S, Inada T, Kodera Y, Kitagawa Y, Omura K, Terashima M, Sakata Y, Nashimoto A, Yamaguchi T, Chin K, Nomura E, Lee SW, Takeuchi M, Fujii M, Nakajima T. Exploratory phase II trial in a multicenter setting to evaluate the clinical value of a chemosensitivity test in patients with gastric cancer (JACCRO-GC 04, Kubota memorial trial). Gastric Cancer. 2016 Apr;19(2):350-360. doi: 10.1007/s10120-015-0506-z. Epub 2015 Sep 18.
Other Identifiers
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GC-04
Identifier Type: -
Identifier Source: secondary_id
JACCRO GC-04
Identifier Type: -
Identifier Source: org_study_id
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