Back to resultsThe Maintenance Treatment of UFT in Advanced Gastric Cancer
Primary Purpose
Gastric Cancer
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
UFT
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Cancer focused on measuring disease control survival
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
UFT treatment
comparator
Arm Description
Uracil and Tegafur
no treatment, follow-up at regular time
Outcomes
Primary Outcome Measures
Progression Free Survival (PFS)
PFS is calculated from the start of treatment to disease progression or death
Secondary Outcome Measures
Overall Survival (OS)
OS is calculated from the start to treatment to the death
Number of Participants with Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02903498
Brief Title
The Maintenance Treatment of UFT in Advanced Gastric Cancer
Official Title
Phase II Study of the Maintenance Treatment of UFT (Uracil and Tegafur) After First-line
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
disease control survival
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
UFT treatment
Arm Type
Experimental
Arm Description
Uracil and Tegafur
Arm Title
comparator
Arm Type
No Intervention
Arm Description
no treatment, follow-up at regular time
Intervention Type
Drug
Intervention Name(s)
UFT
Other Intervention Name(s)
Uracil and Tegafur
Intervention Description
UFT 360mg/m2 qd po d1-14, q3w
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
PFS is calculated from the start of treatment to disease progression or death
Time Frame
six weeks
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is calculated from the start to treatment to the death
Time Frame
six weeks
Title
Number of Participants with Adverse Events
Time Frame
six weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaodong Zhu
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
The Maintenance Treatment of UFT in Advanced Gastric Cancer
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