Clinical trial · Interventional
S-1 Plus Oxaliplatin Compared With Fluorouracil, Leucovorin Calcium Plus Oxaliplatin as Perioperative Chemotherapy for Advanced Gastric Carcinoma
S-1 Plus Oxaliplatin Compared With Fluorouracil, Leucovorin Calcium Plus Oxaliplatin as Perioperative Chemotherapy for Advanced Gastric Carcinoma: a Multi-center, Open-labeled, Randomized Controlled Trial
NCT01364376CI-TRIAL-00023605FocuscompletedN/AClinicalTrials.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)
This is a randomized multicenter controlled study of oxaliplatin, leucovorin calcium , plus 5-fluorouracil (FOLFOX) compared with S-1 plus oxaliplatin (SOX) as perioperative chemotherapy for advanced gastric cancer. Hypothesis: SOX is not inferior to FOLFOX as perioperative chemotherapy for advanced 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 |
|---|---|---|---|
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| S-1; Oxaliplatin; 5-Fu; Leucovorin Calcium | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- FOLFOX
- interventionNames
- Drug: S-1; Oxaliplatin; 5-Fu; Leucovorin Calcium
- type
- EXPERIMENTAL
- label
- SOX
- interventionNames
- Drug: S-1; Oxaliplatin; 5-Fu; Leucovorin Calcium
Primary outcomes (1)
- measure
- overall survival
- timeFrame
- 3-year
Secondary outcomes (4)
- measure
- progression-free survival(PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed gastric adenocarcinoma,diagnosed as locally advanced gastric cancer and primary tumor invades or penetrates serosa * Ambulatory males or females, aged 18-80 years old * ECOG score 0-2 * Given informed consent * Life expectancy more than 3 months * Measurable lesion * Normal cardiac, hepatic, renal, and bone marrow function(WBC:3.5×10\^9/l\~12×10\^9/l;PLT:\>100×109/l;Bil:\<1.5 fold of upper limit value; ALT/AST:\<2.5 fold of upper limit value;Ccr:\>80ml/min;Cr:1.5mg/dl) Exclusion Criteria: * Prior stomach surgery * Previous cytotoxic chemotherapy, radiotherapy, target therapy or immunotherapy for any tumor * History of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix * distant metastasis(such as No.16 and No.13 lymphnode,liver, lung,brain,bones or peritoneal metastasis) * Severe bleeding * Bowel obstruction, ileus or complete pyloric obstruction * Serious uncontrolled concomitant disease * History of myocardial infarction in 6 months * Woman with on-going pregnancy or breast-feeding, or contemplating pregnancy * Systemic treatment with corticosteroid * Patients judged inappropriate for the trial by the physicians
References
Publications (1)
- DERIVEDYu J, Gao Y, Chen L, Wu D, Shen Q, Zhao Z, Liu W, Yang H, Zhang Q, Wang X, Hu P, Zheng Z, Wang X, Liu H, Xu Z, Yan Z, Wu Y, Jin M, Zhang Q, Liu X, Zhu K, Shou C. Effect of S-1 Plus Oxaliplatin Compared With Fluorouracil, Leucovorin Plus Oxaliplatin as Perioperative Chemotherapy for Locally Advanced, Resectable Gastric Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e220426. doi: 10.1001/jamanetworkopen.2022.0426. PMID 35226081