NCT02903498CompletedPhase 2
Phase II Study of the Maintenance Treatment of UFT (Uracil and Tegafur) After First-line
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Fudan University
- Enrollment
- 58
- Primary Endpoint
- Progression Free Survival (PFS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
UFT treatment
Experimental
Uracil and Tegafur
Intervention: UFT (Drug)
Outcomes
Primary Outcomes
Progression Free Survival (PFS)
Time Frame: six weeks
PFS is calculated from the start of treatment to disease progression or death
Secondary Outcomes
- Overall Survival (OS)(six weeks)
- Number of Participants with Adverse Events(six weeks)
Investigators
Xiaodong Zhu
MD, PhD
Fudan University
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