The Maintenance Treatment of UFT in Advanced Gastric Cancer

Phase 2

Completed

• Conditions: Gastric Cancer
• Interventions: Drug: UFT

• 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

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2016-06
• Study Completion: 2016-09
• Study First Submitted: 2016-09-04
• Study First Submitted QC: 2016-09-12
• Study First Posted: 2016-09-16
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-11
• Last Update Posted: 2016-10-12

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