Clinical trial · Interventional
Study of S-1, S-1/CDDP, and 5-FU/CDDP for Advanced Gastric Cancer
An Open-label, Multicenter, Randomized, 3 Arm Study of S-1 Compared With S-1/CDDP, or S-1/CDDP Compared With 5-FU/CDDP in Patients With Advanced Gastric Cancer Previously Untreated With Chemotherapy for Advanced Disease
- 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)
This is an open-label, multicenter, three arm, parallel, randomized, Phase 3 study evaluating the efficacy and safety of S-1 alone compared with S-1 plus CDDP, and S-1 plus CDDP compared with 5-FU plus CDDP in patients with advanced gastric cancer previously untreated with chemotherapy for advanced disease. Patients will be randomly assigned (1:1:1) to S-1 (Arm A), S-1/CDDP (Arm B) or 5-FU/CDDP (Arm C). Patients will be stratified to achieve balanced distribution of patients to each arm according to following stratifications, performance status (0, 1, or 2), the number of metastatic sites (1 vs \>1), prior gastrectomy, and center.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU plus CDDP | Drug | — | UNRESOLVED |
| S-1 | Drug | — | UNRESOLVED |
| S-1 plus CDDP | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- 1
- description
- S-1
- interventionNames
- Drug: S-1
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- S-1 plus CDDP
- interventionNames
- Drug: S-1 plus CDDP
- type
- ACTIVE_COMPARATOR
- label
- 3
- description
- 5-FU plus CDDP
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Non-prior chemotherapy treated advanced gastric adenocarcinoma * Age 18 and over * Performance status 0, 1, or 2 (ECOG) * Life expectancy 3 months * Hematopoietic WBC lower limit of normal-12,000/mm\^3 Absolute granulocyte count ≥ 2,000/mm\^3 Platelet count ≥ 100,000/mm\^3 Hemoglobin ≥ 8.0 g/dL * Hepatic AST and ALT ≤ 100 U/L ALP ≤ 2 times upper limit of normal (ULN) Bilirubin ≤ 1.5 mg/dL * Renal Plasma creatinine ≤ ULN Creatinine clearance ≥ 60 mL/min Exclusion Criteria: * Interstitial pneumonia, pulmonary fibrosis * Myocardial infarction within the last 6 months, severe/unstable angina, congestive heart failure * Intestinal paralysis, intestinal obstruction, uncontrollable diabetes
References
Publications (0)
Data not yet available