Clinical trial · Interventional
Study Evaluating Isovorin in Advanced/Recurrent Gastric Cancer
Post-Approved Phase III Study of 1-LV/5FU Therapy
NCT00195572CI-TRIAL-00002540completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Isovorin | Drug | Levoleucovorin | ALIAS |
| TS-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Survival time
Secondary outcomes (1)
- measure
- Response rate, duration of response, time to progression, safety, quality of life
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 77 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.