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

NCT ID: NCT03636893

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-24
• Study Completion Date: 2025-05-08

Brief Summary

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

Detailed Description

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.

Conditions

Gastric Cancer; Chemotherapy Effect

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FLOT Chemotherapy 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

Group Type: EXPERIMENTAL

FLOT Chemotherapy

Intervention Type: DRUG

5-FU+Leucovorin+Docetaxel+Oxaliplatin

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 1-14 Tegafur gimeracil oteracil potassium capsule 80mg/M2 oral (twice daily)

Repeated every 21st day

Group Type: ACTIVE_COMPARATOR

SOX Chemotherapy

Intervention Type: DRUG

Oxaliplatin+Tegafur gimeracil oteracil potassium capsule (TGO)

Interventions

FLOT Chemotherapy

5-FU+Leucovorin+Docetaxel+Oxaliplatin

Intervention Type: DRUG

SOX Chemotherapy

Oxaliplatin+Tegafur gimeracil oteracil potassium capsule (TGO)

Intervention Type: DRUG

Other Intervention Names

FLOT; SOX

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

BIRENDRA KUMAR SAH

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Birendra Kumar Sah, PH D

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Chen Li, PH D

Role: STUDY_DIRECTOR

Ruijin Hospital

Zhenggang Zhu, PH D

Role: STUDY_CHAIR

Ruijin Hospital

Locations

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 33257672 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Dragon III

Identifier Type: -

Identifier Source: org_study_id