The Maintenance Treatment of UFT in Advanced Gastric Cancer

Phase II Study of the Maintenance Treatment of UFT (Uracil and Tegafur) After First-line

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02903498

Enrollment

Registered

2016-09-16

Start date

2009-08-31

Completion date

2016-09-30

Last updated

2016-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

disease control survival

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.

Interventions

DRUGUFT

UFT 360mg/m2 qd po d1-14, q3w

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Progression Free Survival (PFS)	six weeks	PFS is calculated from the start of treatment to disease progression or death

Secondary

Measure	Time frame	Description
Overall Survival (OS)	six weeks	OS is calculated from the start to treatment to the death
Number of Participants with Adverse Events	six weeks	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026