Clinical trial · Interventional
TOF Versus SOX in Metastatic Gastric Cancer
Paclitaxel/Oxaliplatin/Fluorouracil (TOF) Regimen Versus S-1/Oxaliplatin (SOX) Regimen Metastatic Gastric Cancer Patients
NCT02442362CI-TRIAL-00017902completedPhase 2 / Phase 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)
This study was designed to compare the efficacy and safety of aclitaxel/oxaliplatin/fluorouracil (TOF) regimen and S-1/oxaliplatin (SOX) regimen for metastatic gastric cancer (GC) patients.
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 |
|---|---|---|---|
| oxaliplatin+S1 | Drug | — | UNRESOLVED |
| paclitaxel+oxaliplatin+fluorouracil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- TOF Group
- description
- Patients in the TOF group received chemotherapy with "paclitaxel+oxaliplatin+fluorouracil"
- interventionNames
- Drug: paclitaxel+oxaliplatin+fluorouracil
- type
- EXPERIMENTAL
- label
- SOX Group
- description
- The patients in the SOX group received chemotherapy with 'oxaliplatin+S1'
- interventionNames
- Drug: oxaliplatin+S1
Primary outcomes (1)
- measure
- Tumor respone
- timeFrame
- 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. pathologically confirmed mGC (stage IV) 2. ages between 20 and 80 years 3. measurable or assessable lesions by imaging studies according to the RECIST guideline 21 4. no prior chemotherapy except for postoperative adjuvant chemotherapy for more than 12 months before entry into the study 5. Eastern Cooperative Oncology Group (ECOG) performance status score less than 3 6. hepatic function * total bilirubin ≤ 1.5 × the institutional upper limit of normal value, aspartate aminotransferase/alanine aminotransferase ≤ 2.5 × the institutional upper limit of normal value, and alkaline phosphatase ≤ 2.5 × the institutional upper limit of normal value * renal function (serum creatinine level ≤ 1.5 mg/dL and creatinine clearance ≥ 50 ml/min) * adequate bone marrow function (hemoglobin level ≥ 90 g/L, white blood cell count of 4-10×109/L, neutrophil count ≥ 2×109/L, and platelet count ≥ 100×109/L) 7. estimated life expectancy more than 3 months 8. no other secondary malignant tumors. Exclusion Criteria: 1. preexisted peripheral toxicity ≥ grade 2 of the National Cancer Institute Common Toxicity Criteria 2. concurrent or prior malignancy 3. central nervous system metastases 4. concurrent treatment that interfered with the study evaluation 5. active infection 6. other uncontrolled underlying medical conditions that would impair the ability of the patients to receive the planned treatment 7. having inadequate calorie and fluid intake 8. pregnant, and breastfeeding women or women of child-bearing potential without adequate contraception.
References
Publications (0)
Data not yet available
No reference posted for this study.