Study Evaluating Isovorin in Advanced/Recurrent Gastric Cancer

Post-Approved Phase III Study of 1-LV/5FU Therapy

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00195572

Enrollment

200

Registered

2005-09-19

Start date

2002-05-31

Completion date

2008-08-31

Last updated

2009-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

Gastric Cancer, Advanced/Recurrent Gastric Cancer

Brief summary

The purpose of the study is to verify non-inferiority of survival time between Isovorin/5-fluorouracil (1-LV/5FU) therapy and TS-1 therapy in patients with inoperable advanced or recurrent gastric cancer. Secondary endpoints include response rates, duration of responses, time to progression (TTP) safety and quality of life (QOL).

Interventions

DRUGIsovorin

DRUGTS-1

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 77 Years

Healthy volunteers

Inclusion criteria

* Gastric cancer diagnosed histologically or cytologically * Normal organ function of bone marrow, heart, liver and kidney * Age of 20-77 Other inclusion applies

Exclusion criteria

* Serious infection, heart disease, complication or organ disorder * Ongoing administration of flucytosine * Pregnant or breastfeeding women Other exclusion applies

Design outcomes

Primary

Measure	Time frame
Survival time	—

Secondary

Measure	Time frame
Response rate, duration of response, time to progression, safety, quality of life	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026