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Safety and efficacy study of neoadjuvant chemotherapy (FLOT versus SOX) for gastric cancer patients in high volume center of China
DRAGON III research, Neoadjuvant Chemotherapy (FLOT versus SOX) for Gastric Cancer, is an investigator initiated; phase II, open label, randomised controlled study. This study will be conducted and analyzed by the Gastrointestinal department（Unit III）of the Ruijin Hospital and the project is supported by the Institute of Digestive Surgery, Shanghai, which is a state key research center. This study will be monitored by the Clinical Research Center of the Ruijin hospital (Official body which is responsible to guide and monitor all types of research at Ruijin hospital). Primary endpoint and secondary endpoint is described above. The aim of this study to obtain preliminary result and further conduct a large scale multi-center randomised controlled trial(RCT) study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLOT Chemotherapy regimen | Experimental | 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 |
|
| SOX Chemotherapy regimen | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FLOT Chemotherapy | Drug | 5-FU+Leucovorin+Docetaxel+Oxaliplatin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Percentage of Patients With Pathological Complete Tumor Regression (TRG1a) and Sub-total Tumor Regression (TRG1b) in the Primary Tumour | Tumor regression grade (TRG), Becker criteria Grade 1a :Complete tumor regression: 0% residual tumor per tumor bed Grade 1b: Subtotal tumor regression: <10% residual tumor per tumor bed Grade 2: Partial tumor regression: 10-50% residual tumor per tumor bed Grade 3: Minimal or no tumor regression: >50% residual tumor per tumor bed | Three months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free Survival (DFS) | Time from randomization to the first occurrence of local recurrence, regional recurrence, distant metastases, or death from any cause. Disease recurrence was assessed using CT imaging with contrast, upper endoscopy for local recurrence, histological confirmation when feasible, and multidisciplinary team review of imaging findings. | From randomization through 5 years follow-up (median follow-up 65.7 months) |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Birendra Kumar Sah, PH D | Ruijin Hospital | Principal Investigator |
| Chen Li, PH D | Ruijin Hospital | Study Director |
| Zhenggang Zhu, PH D | Ruijin Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200025 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41181842 | Derived | Sah 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. | |
| 33257672 |
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| ID | Title | Description |
|---|---|---|
| FG000 | FLOT Chemotherpy Regimen | 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 Three drug Chemotherapy: 5-FU+Leucovorin+Docetaxel+Oxaliplatin |
| FG001 | SOX Chemotherapy Regimen | Three preoperative cycles and three postoperative cycles of SOX chemotherapy administered A cycle consists of Day 1: Oxaliplatin 130mg/M2 intravenous Day 1-14 Tegafur gimeracil oteracil (TGO) potassium capsule 80mg/M2 oral (twice daily) Repeated every 21st day Two drug Chemotherapy: Oxaliplatin+TGO |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Per protocol(PP) population
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| ID | Title | Description |
|---|---|---|
| BG000 | FLOT Chemotherpy Regimen | A total of four preoperative and four postoperative cycles of FLOT chemotherapy administered A cycle consists of Day 1 5-FU 2600mg/M2 administered via intravenous PICC for 24 hour Leucovorin 200mg/M2 intravenous Oxaliplatin 85mg/ M2 intravenous Docetaxel 50mg/M2 intravenous Repeated every 15th day Three drug Chemotherapy: 5-FU+Leucovorin+Docetaxel+Oxaliplatin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Percentage of Patients With Pathological Complete Tumor Regression (TRG1a) and Sub-total Tumor Regression (TRG1b) in the Primary Tumour | Tumor regression grade (TRG), Becker criteria Grade 1a :Complete tumor regression: 0% residual tumor per tumor bed Grade 1b: Subtotal tumor regression: <10% residual tumor per tumor bed Grade 2: Partial tumor regression: 10-50% residual tumor per tumor bed Grade 3: Minimal or no tumor regression: >50% residual tumor per tumor bed | Intention-to-treat (ITT) population | Posted | Count of Participants | Participants | Three months |
|
From randomization through 5 years follow-up (median follow-up 65.7 months)
All 74 randomized participants were assessed for all-cause mortality per intention-to-treat analysis. According to the study protocol, serious adverse events and other adverse events were systematically collected for all 74 participants during the study period, including events leading to treatment discontinuation. Adverse events leading to dropout were captured as protocol violations or serious adverse events as appropriate.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FLOT Chemotherpy Regimen | A total of four preoperative and four postoperative cycles of FLOT chemotherapy administered A cycle consist of Day 1 5-FU 2600mg/M2 administered via intravenous PICC for 24 hour Leucovorin 200mg/M2 intravenous Oxaliplatin 85mg/ M2 intravenous Docetaxel 50mg/M2 intravenous Repeated every 15th day Three drug Chemotherapy: 5-FU+CF+Docetaxel+Oxaliplatin |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Overall postoperative complication | Surgical and medical procedures | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Grade 3+Grade 4 Decrease in white blood cells | Blood and lymphatic system disorders | Non-systematic Assessment | Common Terminology Criteria for Adverse Events (CTCAE)Version 4.0: Decrease in white blood cells |
This is a preliminary result of phase II study with inadequate sample numbers. A phase III multi center randomised controlled trial is necessary to justify these results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr BIRENDRA KUMAR SAH | RUIJIN HOSPITAL | 0086-64370045 | 671302 | rjsurgeon@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 10, 2017 | May 14, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Randomly assigned(1:1) either to FLOT or SOX group.
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| SOX Chemotherapy | Drug | Oxaliplatin+Tegafur gimeracil oteracil potassium capsule (TGO) |
|
|
| Overall Survival (OS) | Time from randomization to death from any cause. Patients alive at the time of analysis were censored on the date of the last follow-up visit. Vital status was verified through multiple sources: direct clinical follow-up, telephone contact, cross-referencing with local death registry records, and review of medical records from other healthcare facilities. | From randomization through 5 years follow-up (median follow-up 65.7 months) |
| Sah 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. |
| Withdrawal by Subject |
|
| Refusal to surgery |
|
| Early surgery (for acute bleeding) |
|
| Adverse Event |
|
| BG001 | SOX Chemotherapy Regimen | Three preoperative cycles and three postoperative cycles of SOX chemotherapy administered A cycle consists of Day 1: Oxaliplatin 130mg/M2 intravenous Day 1-14 Tegafur gimeracil oteracil (TGO) potassium capsule 80mg/M2 oral (twice daily) Repeated every 21st day Two drug Chemotherapy: Oxaliplatin+TGO |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Median | Full Range | kg/m^2 |
|
| OG001 | SOX Chemotherapy Regimen | Three preoperative cycles and three postoperative cycles of SOX chemotherapy administered A cycle consist of Day 1: Oxaliplatin 130mg/M2 intravenous Day 1-14Tegafur gimeracil oteracil potassium capsule 80mg/M2 oral (twice daily) Repeated every 21st day Two drug Chemotherapy: Oxaliplatin+TGO |
|
|
| Secondary | Disease-free Survival (DFS) | Time from randomization to the first occurrence of local recurrence, regional recurrence, distant metastases, or death from any cause. Disease recurrence was assessed using CT imaging with contrast, upper endoscopy for local recurrence, histological confirmation when feasible, and multidisciplinary team review of imaging findings. | Intention-to-treat population including all 74 randomized patients regardless of treatment completion or protocol adherence. Complete vital status obtained for all patients with median follow-up of 65.7 months. | Posted | Median | 95% Confidence Interval | months | From randomization through 5 years follow-up (median follow-up 65.7 months) |
|
|
|
|
| Secondary | Overall Survival (OS) | Time from randomization to death from any cause. Patients alive at the time of analysis were censored on the date of the last follow-up visit. Vital status was verified through multiple sources: direct clinical follow-up, telephone contact, cross-referencing with local death registry records, and review of medical records from other healthcare facilities. | Intention-to-treat population including all 74 randomized patients regardless of treatment completion or protocol adherence. Complete vital status obtained for all patients. At data cut-off, 41 deaths occurred: 21 (52.5%) in FLOT group and 20 (58.8%) in SOX group. | Posted | Median | 95% Confidence Interval | months | From randomization through 5 years follow-up (median follow-up 65.7 months) |
|
|
|
|
| 21 |
| 40 |
| 9 |
| 40 |
| 9 |
| 40 |
| EG001 | SOX Chemotherapy Regimen | Three preoperative cycles and three postoperative cycles of SOX chemotherapy administered A cycle consist of Day 1: Oxaliplatin 130mg/M2 intravenous Day 1-14Tegafur gimeracil oteracil potassium capsule 80mg/M2 oral (twice daily) Repeated every 21st day Two drug Chemotherapy: Oxaliplatin+TGO | 20 | 34 | 8 | 34 | 5 | 34 |
| Postoperative complications: Death | Surgical and medical procedures | Systematic Assessment |
|
| Grade IV hematological toxicity with multiple organ failure | Blood and lymphatic system disorders | Non-systematic Assessment | Grade IV hematological toxicity with multiple organ failure |
|
| Acute cerebral infarction | Nervous system disorders | Non-systematic Assessment | Acute cerebral infarction |
|
| Deep venous thrombosis | Vascular disorders | Non-systematic Assessment | Deep venous thrombosis |
|
|
| Grade 3+Grade 4 Neutrophil count decreased | Blood and lymphatic system disorders | Systematic Assessment |
|
| Grade 3+Grade 4 Platelet count decreased | Blood and lymphatic system disorders | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| ALT | Hepatobiliary disorders | Systematic Assessment |
|
| AST | Hepatobiliary disorders | Systematic Assessment |
|
| Acute bleeding requiring emergency surgery | Gastrointestinal disorders | Non-systematic Assessment | Acute bleeding requiring emergency surgery |
|
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| Other |
Two-sided log-rank test comparing disease-free survival between treatment groups. No adjustment for multiple comparisons as this was a pre-specified secondary endpoint. Statistical significance set at P <0.05. |
Kaplan-Meier method used to estimate DFS curves. Cox regression performed to calculate hazard ratios. |
| Other |
Two-sided log-rank test comparing overall survival between treatment groups. No adjustment for multiple comparisons as this was a pre-specified secondary endpoint. Statistical significance set at P <0.05. |
Kaplan-Meier method used to estimate survival curves. Cox regression performed to calculate hazard ratios. Multivariable analysis performed to identify independent predictors. |