The Maintenance Treatment of UFT in Advanced Gastric Cancer
- Registration Number
- NCT02903498
- Lead Sponsor
- Fudan University
- Brief Summary
The purpose of this study is to evaluate the efficacy and tolerability of the maintenance treatment of tegafur-uracil (UFT) after the standard first-line chemotherapy in advanced gastric cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
Inclusion Criteria
- Histologically confirmed advanced or metastatic adenocarcinoma of the stomach
- 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
- Receiving more or more than 2 regimens of chemotherapy
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description UFT treatment UFT Uracil and Tegafur
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) six weeks PFS is calculated from the start of treatment to disease progression or death
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) six weeks OS is calculated from the start to treatment to the death
Number of Participants with Adverse Events six weeks