The Maintenance Treatment of UFT in Advanced Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02903498
• Other study ID #: UFT maintenance in GC
• Status: Completed
• Phase: Phase 2
• First received: September 4, 2016
• Last updated: October 11, 2016
• Start date: August 2009
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)	PFS is calculated from the start of treatment to disease progression or death	six weeks	No
Secondary	Overall Survival (OS)	OS is calculated from the start to treatment to the death	six weeks	No
Secondary	Number of Participants with Adverse Events		six weeks	Yes