The Maintenance Treatment of UFT in Advanced Gastric Cancer
Phase II Study of the Maintenance Treatment of UFT (Uracil and Tegafur) After First-line
1 other identifier
interventional
58
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 gastric-cancer
Started Aug 2009
Longer than P75 for phase_2 gastric-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 4, 2016
CompletedFirst Posted
Study publicly available on registry
September 16, 2016
CompletedOctober 12, 2016
October 1, 2016
6.8 years
September 4, 2016
October 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
PFS is calculated from the start of treatment to disease progression or death
six weeks
Secondary Outcomes (2)
Overall Survival (OS)
six weeks
Number of Participants with Adverse Events
six weeks
Study Arms (2)
UFT treatment
EXPERIMENTALUracil and Tegafur
comparator
NO INTERVENTIONno treatment, follow-up at regular time
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaodong Zhu
Fudan University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
September 4, 2016
First Posted
September 16, 2016
Study Start
August 1, 2009
Primary Completion
June 1, 2016
Study Completion
September 1, 2016
Last Updated
October 12, 2016
Record last verified: 2016-10