The Maintenance Treatment of UFT in Advanced Gastric Cancer

Fudan University

Status and phase: Completed; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: UFT

Study type: Interventional

Funder types: Other

Identifiers

NCT02903498

UFT maintenance in GC

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

UFT treatment

Experimental group

Description:

Uracil and Tegafur

Treatment:

Drug: UFT

comparator

No Intervention group

Description:

no treatment, follow-up at regular time