Clinical trial · Interventional
S-1 and Cisplatin Before Surgery in Treating Patients With Stage IV Gastric Cancer
Phase II Clinical Study of Preoperative S-1/CDDP Combination Chemotherapy in Patients With Advanced Gastric Cancer
- 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)
RATIONALE: Drugs used in chemotherapy, such as S-1 and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Giving combination chemotherapy before surgery may shrink the tumor so that it can be removed. PURPOSE: This phase II trial is studying how well giving S-1 together with cisplatin works in treating patients who are undergoing surgery for stage IV gastric cancer.
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| cisplatin | Drug | Cisplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| tegafur-gimeracil-oteracil potassium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Overall survival
Secondary outcomes (8)
- measure
- Time to progression
- measure
- Tumor response
- measure
- Death related to treatment
- measure
- Histological response
- measure
- Postoperative complications
- measure
- Surgical/pathological curative resection
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed gastric adenocarcinoma
* Stage IV disease meeting 1 of the following staging criteria according to Japanese gastric cancer classification:
* T4, N2
* T4, N3
* P1, CY1
* CT scan and laparoscopic staging required
PATIENT CHARACTERISTICS:
Age
* 20 and over
Performance status
* ECOG 0-1
Life expectancy
* Not specified
Hematopoietic
* WBC ≥ 4,000/mm\^3 AND \< 12,000/mm\^3
* Granulocyte count ≥ 2,000/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9.0 g/dL
Hepatic
* AST and ALT ≤ 2.5 times upper limit of normal
* Bilirubin ≤ 1.5 mg/dL
Renal
* Creatinine clearance ≥ 50 mL/min
Pulmonary
* PaO\_2 ≥ 70 mm Hg on room air
Other
* Able to swallow oral medication
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy for gastric cancer
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy for gastric cancer
Surgery
* No prior surgery for gastric cancer
Other
* No other prior therapy for gastric cancerReferences
Publications (1)
- RESULTSatoh S, Okabe H, Teramukai S, Hasegawa S, Ozaki N, Ueda S, Tsuji A, Sakabayashi S, Fukushima M, Sakai Y. Phase II trial of combined treatment consisting of preoperative S-1 plus cisplatin followed by gastrectomy and postoperative S-1 for stage IV gastric cancer. Gastric Cancer. 2012 Jan;15(1):61-9. doi: 10.1007/s10120-011-0066-9. Epub 2011 Jun 11. PMID 21667134