The Maintenance Treatment of UFT in Advanced Gastric Cancer | NCT02903498

Studies
The Maintenance Treatment of UFT in Advanced Gastric Cancer

NCT02903498

Sponsor

Fudan University

Status

Completed

Last Update Posted

Oct 12, 2016Estimated

Enrollment

58Actual

Phase

Phase 2

Conditions

Gastric Cancer

Interventions

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Jun 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Sep 4, 2016

First Submission Date that Met QC Criteria

Sep 12, 2016

First Posted Date

Sep 16, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 11, 2016

Last Update Posted Date

Oct 12, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

58Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
UFT treatment	Experimental	Uracil and Tegafur	Drug: UFT
comparator	No Intervention	no treatment, follow-up at regular time

Interventions

Name	Type	Description	Arm Group Labels	Other Names
UFT	Drug	UFT 360mg/m2 qd po d1-14, q3w	UFT treatment	Uracil and Tegafur

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Xiaodong Zhu	Fudan University	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005641	Tegafur

Ancestor Terms

ID	Term
D005472	Fluorouracil
D014498	Uracil
D011744	Pyrimidinones
D011743	Pyrimidines
D006573

Browse Leaves

Not provided

Browse Branches

Not provided