The Maintenance Treatment of UFT in Advanced Gastric Cancer
NCT ID: NCT02903498
Last Updated: 2016-10-12
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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COMPLETED
PHASE2
58 participants
INTERVENTIONAL
2009-08-31
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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UFT treatment
Uracil and Tegafur
UFT
UFT 360mg/m2 qd po d1-14, q3w
comparator
no treatment, follow-up at regular time
No interventions assigned to this group
Interventions
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UFT
UFT 360mg/m2 qd po d1-14, q3w
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ECOG PS 0-2
* At least one measurable or evaluable lesion in the first-line chemotherapy (5-FU based regimen: ECF/EOF/EOX/FOLFOX/XELOX) with the efficacy evaluation of non-PD
* Adequate hepatic,renal,heart, and hematologic functions (platelets ≥75×109/L, neutrophil≥1.5×109/L, hemoglobin≥80 g/L, serum creatinine ≤1.5mg/dl, total bilirubin ≤1.5mg/dl, and serum transaminase≤2.5×the ULN)
Exclusion Criteria
* Pregnant or lactating women
* Concurrent cancer
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
* Neuropathy, brain, or leptomeningeal involvement
* Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or high risk/uncontrolled arrhythmia
* Uncontrolled significant comorbid conditions and previous radiotherapy
18 Years
75 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Xiaodong Zhu
MD, PhD
Principal Investigators
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Xiaodong Zhu
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Other Identifiers
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UFT maintenance in GC
Identifier Type: -
Identifier Source: org_study_id
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