Clinical trial · Interventional
Diffuse Gastric and Esophagogastric Junction Cancer S-1 Trial
An Open-Label, Multicenter, Randomized, Phase 3 Study of S-1 and Cisplatin Compared With 5-FU and Cisplatin in Patients With Metastatic Diffuse Gastric Cancer Previously Untreated With Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to significant changes in investigational and clinical practice landscape of frontline advanced gastric cancer, which challenged viability of trial and increased use of modified chemotherapeutic triplets led to slow participant accrual in study.
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and efficacy of S-1 and Cisplatin compared to 5-FU and Cisplatin in treatment of patients with metastatic diffuse gastric and gastro-esophageal junction cancer previously untreated with chemotherapy.
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 |
|---|---|---|---|
| Metastatic Diffuse Gastric Cancer Including Carcinoma of the Gastro-esophageal Junction | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluorouracil/cisplatin (control arm) | Drug | — | UNRESOLVED |
| S-1 (Tegafur+Gimeracil+Oteracil) /cisplatin (investigational arm) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- S-1+Cisplatin
- description
- Participants received S-1 25 milligrams per meter square (mg/m\^2) orally twice daily (BID) every 12 hours from Day 1 through Day 21, 1 hour before or after meal with a glass of water; followed by a 7-day rest period from Day 22 to Day 28 in a 28-day cycle. Participants received a single dose of cisplatin 75 mg/m\^2 as a 1- to 3-hour intravenous (IV) infusion on Day 1 following the morning dose of S-1 for a maximum of 8 cycles (each cycle of 28 days). Participants received study medication until progression of disease (PD), adverse event (AE), withdrawal of consent, or other reason for discontinuation, whichever happened earlier.
- interventionNames
- Drug: S-1 (Tegafur+Gimeracil+Oteracil) /cisplatin (investigational arm)
- type
- ACTIVE_COMPARATOR
- label
- 5FU+Cisplatin
- description
- Participants received 5-Fluorouracil (5-FU) 800 mg/m\^2 per 24 hours as continuous IV infusion over 120 hours from Day 1 through Day 5 followed by a 16-day rest period on Days 6 through 21 in a 21-day cycle. Participants received a single dose of cisplatin 80 mg/m\^2 as a 1- to 3-hour IV infusion on Day 1 prior to the start of the 5-FU infusion on Day 1 for a maximum of 8 cycles (each cycle of 21 days). Participants received study medication until PD, AE, withdrawal of consent, or other reason for discontinuation, whichever happened earlier.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Has given written Informed Consent. * Histologically confirmed, unresectable, metastatic diffuse gastric cancer including carcinoma of the gastro-esophageal junction. * No prior chemotherapy for gastric cancer except adjuvant and/or neo-adjuvant chemotherapy more than 12 months ago. * Life expectancy of at least 3 months. * Able to take medications orally. * Eastern Cooperative Oncology Group performance status 0 to 1. * Adequate organ function (bone marrow, kidney and liver). Exclusion Criteria: * Certain type(s) of non-measurable lesion(s), if the only one(s). * Certain serious illness or medical condition(s). * Lost greater than or equal to 10% of body weight in the 3 months proceeding signing the Informed Consent Form. * Treatment with drugs interacting with S-1, 5-FU, or cisplatin. * Pregnant or lactating female. * Known hypersensitivity to fluoropyrimidines or cisplatin. Other protocol-defined inclusion/exclusion criteria may apply.
References
Publications (1)
- DERIVEDAjani JA, Abramov M, Bondarenko I, Shparyk Y, Gorbunova V, Hontsa A, Otchenash N, Alsina M, Lazarev S, Feliu J, Elme A, Esko V, Abdalla K, Verma U, Benedetti F, Aoyama T, Mizuguchi H, Makris L, Rosati G; DIGEST Study Group. A phase III trial comparing oral S-1/cisplatin and intravenous 5-fluorouracil/cisplatin in patients with untreated diffuse gastric cancer. Ann Oncol. 2017 Sep 1;28(9):2142-2148. doi: 10.1093/annonc/mdx275. PMID 28911091