Trial Outcomes & Findings for Dragon III: Neoadjuvant Chemotherapy (FLOT Versus SOX) for Gastric Cancer (NCT NCT03636893)

Last Updated: 2025-07-23

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

74 participants

Primary outcome timeframe

Three months

Results posted on

2025-07-23

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	40	34
Overall Study COMPLETED	31	24
Overall Study NOT COMPLETED	9	10

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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
Overall Study Death	0	1
Overall Study Protocol Violation	0	3
Overall Study Withdrawal by Subject	1	2
Overall Study Refusal to surgery	4	3
Overall Study Early surgery (for acute bleeding)	3	0
Overall Study Adverse Event	1	1

Baseline Characteristics

Dragon III: Neoadjuvant Chemotherapy (FLOT Versus SOX) for Gastric Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FLOT Chemotherpy Regimen n=31 Participants 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	SOX Chemotherapy Regimen n=24 Participants 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	Total n=55 Participants Total of all reporting groups
Age, Customized <=60	7 Participants n=5 Participants	14 Participants n=7 Participants	21 Participants n=5 Participants
Age, Customized 61-70	16 Participants n=5 Participants	7 Participants n=7 Participants	23 Participants n=5 Participants
Age, Customized 71-80	8 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	14 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	31 Participants n=5 Participants	24 Participants n=7 Participants	55 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment China	31 participants n=5 Participants	24 participants n=7 Participants	55 participants n=5 Participants
BMI	23.56 kg/m^2 n=5 Participants	23.49 kg/m^2 n=7 Participants	23.56 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: Three months

Population: Intention-to-treat (ITT) population

Outcome measures

Outcome measures
Measure	FLOT Chemotherpy Regimen n=40 Participants 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	SOX Chemotherapy Regimen n=34 Participants 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
Total Percentage of Patients With Pathological Complete Tumor Regression (TRG1a) and Sub-total Tumor Regression (TRG1b) in the Primary Tumour Grade 1a: Complete tumor regression	1 Participants	0 Participants
Total Percentage of Patients With Pathological Complete Tumor Regression (TRG1a) and Sub-total Tumor Regression (TRG1b) in the Primary Tumour Grade 1b: Subtotal tumor regression	7 Participants	11 Participants
Total Percentage of Patients With Pathological Complete Tumor Regression (TRG1a) and Sub-total Tumor Regression (TRG1b) in the Primary Tumour Grade 2: Partial tumor regression	13 Participants	7 Participants
Total Percentage of Patients With Pathological Complete Tumor Regression (TRG1a) and Sub-total Tumor Regression (TRG1b) in the Primary Tumour Grade 3: Minimal or no tumor regression	10 Participants	6 Participants
Total Percentage of Patients With Pathological Complete Tumor Regression (TRG1a) and Sub-total Tumor Regression (TRG1b) in the Primary Tumour Pathology not available	9 Participants	10 Participants

SECONDARY outcome

Timeframe: From randomization through 5 years follow-up (median follow-up 65.7 months)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	FLOT Chemotherpy Regimen n=40 Participants 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	SOX Chemotherapy Regimen n=34 Participants 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
Disease-free Survival (DFS)	23.0 months Interval 8.0 to 38.0	25.5 months Interval 12.0 to 38.9

SECONDARY outcome

Timeframe: From randomization through 5 years follow-up (median follow-up 65.7 months)

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.

Outcome measures

Outcome measures
Measure	FLOT Chemotherpy Regimen n=40 Participants 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	SOX Chemotherapy Regimen n=34 Participants 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
Overall Survival (OS)	61.5 months Interval 61.5 to Upper CI limit not estimable - median survival not reached due to \>50% of FLOT patients remaining alive at data cutoff.	67.8 months Interval 25.7 to 109.9

Adverse Events

FLOT Chemotherpy Regimen

Serious events: 9 serious events

Other events: 9 other events

Deaths: 21 deaths

SOX Chemotherapy Regimen

Serious events: 8 serious events

Other events: 5 other events

Deaths: 20 deaths

Serious adverse events

Serious adverse events
Measure	FLOT Chemotherpy Regimen n=40 participants at risk 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	SOX Chemotherapy Regimen n=34 participants at risk 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
Surgical and medical procedures Overall postoperative complication	22.5% 9/40 • 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.	23.5% 8/34 • 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.
Surgical and medical procedures Postoperative complications: Death	0.00% 0/40 • 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.	0.00% 0/34 • 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.
Blood and lymphatic system disorders Grade IV hematological toxicity with multiple organ failure	0.00% 0/40 • 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.	2.9% 1/34 • 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.
Nervous system disorders Acute cerebral infarction	2.5% 1/40 • 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.	0.00% 0/34 • 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.
Vascular disorders Deep venous thrombosis	0.00% 0/40 • 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.	2.9% 1/34 • 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.

Other adverse events

Other adverse events
Measure	FLOT Chemotherpy Regimen n=40 participants at risk 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	SOX Chemotherapy Regimen n=34 participants at risk 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
Blood and lymphatic system disorders Grade 3+Grade 4 Decrease in white blood cells	2.5% 1/40 • 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.	0.00% 0/34 • 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.
Blood and lymphatic system disorders Grade 3+Grade 4 Neutrophil count decreased	5.0% 2/40 • 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.	5.9% 2/34 • 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.
Blood and lymphatic system disorders Grade 3+Grade 4 Platelet count decreased	2.5% 1/40 • 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.	0.00% 0/34 • 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.
Blood and lymphatic system disorders Anemia	10.0% 4/40 • 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.	5.9% 2/34 • 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.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/40 • 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.	2.9% 1/34 • 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.
Hepatobiliary disorders ALT	0.00% 0/40 • 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.	0.00% 0/34 • 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.
Hepatobiliary disorders AST	2.5% 1/40 • 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.	0.00% 0/34 • 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.
Gastrointestinal disorders Acute bleeding requiring emergency surgery	7.5% 3/40 • 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.	0.00% 0/34 • 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.

Additional Information

Dr BIRENDRA KUMAR SAH

RUIJIN HOSPITAL

Phone: 0086-64370045

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place