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

Last updated: July 21, 2025
Sponsor: Ruijin Hospital
Overall Status: Completed

Phase

2

Condition

Gastric Cancer

Digestive System Neoplasms

Stomach Cancer

Treatment

SOX Chemotherapy

FLOT Chemotherapy

Clinical Study ID

NCT03636893
Dragon III
  • Ages 18-80
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Histology confirmed non-obstructive adenocarcinoma of the stomach or esophagogastricjunction.

  • Clinical stage: cTNM: stage III or above

  • Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2 (normal tosymptomatic but in bed less than half the day)

  • Clinically fit for systemic chemotherapy and gastric cancer surgery, i.e. adequaterenal, hepatic, hematologic, and pulmonary function.

  • Written informed consent

Exclusion

Exclusion criteria:

  • Clinically unfit for systemic chemotherapy and gastric cancer surgery, i.e.uncontrolled cardiac disease, or other clinically significant uncontrolledcomorbidities, 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

Study Design

Total Participants: 74
Treatment Group(s): 2
Primary Treatment: SOX Chemotherapy
Phase: 2
Study Start date:
August 24, 2018
Estimated Completion Date:
May 08, 2025

Study 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.

Connect with a study center

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai 200025
    China

    Site Not Available

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