NCT03636893

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

Dragon III- Phase 2: The Preliminary Efficacy Study of FLOT Versus SOX Regimen as Neoadjuvant Chemotherapy for Patients With Locally Advanced Gastric Cancer: Open-label, Randomized Controlled Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	FLOT Chemotherapy	5-FU+Leucovorin+Docetaxel+Oxaliplatin
DRUG	SOX Chemotherapy	Oxaliplatin+Tegafur gimeracil oteracil potassium capsule (TGO)

Timeline

• Start date: 2018-08-24
• Primary completion: 2020-03-31
• Completion: 2025-05-08
• First posted: 2018-08-17
• Last updated: 2025-07-23
• Results posted: 2020-06-22

Locations

1 site across 1 country: China