A Phase II Trial of Adjuvant Chemotherapy With S-1 Plus Oxaliplatin for Locally Advanced Gastric Cancer
NCT ID: NCT01946061
Last Updated: 2016-08-19
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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TERMINATED
PHASE2
3 participants
INTERVENTIONAL
2015-05-31
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment group
S-1 plus oxaliplatin
Patients will receive adjuvant chemotherapy of eight 3-week cycles of oral S-1 (70 mg/m2/day on days 1 to 14 of each cycle) plus intravenous oxaliplatin (130 mg/m2 on day 1 of each cycle) for 6 months after D2 gastrectomy.
Interventions
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S-1 plus oxaliplatin
Patients will receive adjuvant chemotherapy of eight 3-week cycles of oral S-1 (70 mg/m2/day on days 1 to 14 of each cycle) plus intravenous oxaliplatin (130 mg/m2 on day 1 of each cycle) for 6 months after D2 gastrectomy.
Eligibility Criteria
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Inclusion Criteria
* Histologically proven advanced gastric cancer
* R0 resection after D2 gastrectomy
* Stage III (according to the AJCC 7th criteria)
* ECOG status 0 to 2
Exclusion Criteria
* Previous chemotherapy history for gastric cancer
* Previous radiotherapy history for gastric cancer
* Pregnancy or breast milk feeding
* Grade 3 or more of neuropathy
* Active infection
* Severe hepatic dysfunction
* Severe renal dysfunction
* Severe bone marrow dysfunction
* Significant neurologic or psychologic disease
* Inadequate condition for receiving chemotherapy due to significant systemic disease
* Patients who receives drugs which can be interacted with S-1
19 Years
75 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Severnace Hospital
Seoul, , South Korea
Countries
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References
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Sakuramoto S, Sasako M, Yamaguchi T, Kinoshita T, Fujii M, Nashimoto A, Furukawa H, Nakajima T, Ohashi Y, Imamura H, Higashino M, Yamamura Y, Kurita A, Arai K; ACTS-GC Group. Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med. 2007 Nov 1;357(18):1810-20. doi: 10.1056/NEJMoa072252.
Other Identifiers
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4-2013-0452
Identifier Type: -
Identifier Source: org_study_id
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