Clinical trial · Interventional
Dragon III: Neoadjuvant Chemotherapy (FLOT Versus SOX) for Gastric Cancer
Dragon III- Phase 2: The Preliminary Efficacy Study of FLOT Versus SOX Regimen as Neoadjuvant Chemotherapy for Patients With Locally Advanced Gastric Cancer: Open-label, Randomized Controlled Trial
NCT03636893CI-TRIAL-00092476completedPhase 2Results postedClinicalTrials.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)
Safety and efficacy study of neoadjuvant chemotherapy (FLOT versus SOX) for gastric cancer patients in high volume center of China
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy Effect | — | UNRESOLVED | — |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FLOT Chemotherapy | Drug | — | UNRESOLVED |
| SOX Chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- FLOT Chemotherapy regimen
- description
- A total of four preoperative and four postoperative cycles of FLOT chemotherapy administered A cycle consists of Day 1 5-fluorouracil(5-FU) 2600mg/M2 administered via an intravenous peripherally inserted central venous catheter(PICC) for 24 hour Leucovorin 200mg/M2 intravenous Oxaliplatin 85mg/ M2 intravenous Docetaxel 50mg/M2 intravenous Repeated every 15th day
- interventionNames
- Drug: FLOT Chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- SOX Chemotherapy regimen
- description
- Three preoperative cycles and three postoperative cycles of SOX chemotherapy administered A cycle consist of Day 1: Oxaliplatin 130mg/M2 intravenous Day 1-14 Tegafur gimeracil oteracil potassium capsule 80mg/M2 oral (twice daily) Repeated every 21st day
- interventionNames
- Drug: SOX Chemotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion criteria: * Histology confirmed non-obstructive adenocarcinoma of the stomach or esophagogastric junction. * Clinical stage: cTNM: stage III or above * Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2 (normal to symptomatic but in bed less than half the day) * Clinically fit for systemic chemotherapy and gastric cancer surgery, i.e. adequate renal, hepatic, hematologic, and pulmonary function. * Written informed consent Exclusion criteria: * Clinically unfit for systemic chemotherapy and gastric cancer surgery, i.e. uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities, unable to undergo general anesthesia * Confirmed distant metastases * Locally advanced inoperable disease (Clinical assessment) * Relapse of gastric cancer * Malignant secondary disease * Prior chemo or radiotherapy * Inclusion in another clinical trial * Known contraindications or hypersensitivity for planned chemotherapy
References
Publications (2)
- DERIVEDSah BK, Yu Z, Zhang B, Yuan F, Zhang H, Li J, Ma T, Shi M, Zhu Z, Zheng Y, Liu W, Yan C, Li C, Zhu Z. Neoadjuvant FLOT versus SOX chemotherapy in locally advanced gastric cancer: secondary outcomes of a single-centre, open-label, randomised, exploratory phase 2 trial. EClinicalMedicine. 2025 Oct 5;88:103494. doi: 10.1016/j.eclinm.2025.103494. eCollection 2025 Oct. PMID 41181842
- DERIVEDSah BK, Zhang B, Zhang H, Li J, Yuan F, Ma T, Shi M, Xu W, Zhu Z, Liu W, Yan C, Li C, Liu B, Yan M, Zhu Z. Neoadjuvant FLOT versus SOX phase II randomized clinical trial for patients with locally advanced gastric cancer. Nat Commun. 2020 Nov 30;11(1):6093. doi: 10.1038/s41467-020-19965-6. PMID 33257672