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

NCT03636893 | Completed Phase 2 Results DMC

• 1 other identifier: Dragon III
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Safety and efficacy study of neoadjuvant chemotherapy (FLOT versus SOX) for gastric cancer patients in high volume center of China

Conditions

Gastric Cancer; Chemotherapy Effect

Keywords

Neoadjuvant chemotherapy; perioperative chemotherapy; Systemic chemotherapy; FLOT; SOX; Gastric cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Disease-free Survival (DFS)

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

• Overall Survival (OS)

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

Study Arms (2)

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

Drug: FLOT Chemotherapy

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

Drug: SOX Chemotherapy

Interventions

FLOT Chemotherapy DRUG

5-FU+Leucovorin+Docetaxel+Oxaliplatin

Also known as: FLOT

FLOT Chemotherapy regimen

SOX Chemotherapy DRUG

Oxaliplatin+Tegafur gimeracil oteracil potassium capsule (TGO)

Also known as: SOX

SOX Chemotherapy regimen

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Known contraindications or hypersensitivity for planned chemotherapy

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (2)

• 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.

  PMID: 41181842 DERIVED

• 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.

  PMID: 33257672 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr BIRENDRA KUMAR SAH
• Organization: RUIJIN HOSPITAL

rjsurgeon@hotmail.com

0086-64370045

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomly assigned(1:1) either to FLOT or SOX group.

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 17, 2018
• Study Start: August 24, 2018
• Primary Completion: March 31, 2020
• Study Completion: May 8, 2025
• Last Updated: July 23, 2025
• Results First Posted: June 22, 2020

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)